42 Cqa Jobs

Division Department Sub Department 1 Job Purpose Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines Key Accountabilities (1/6) Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner Collect data from all SPOCs with respect to received work plan for review Escalate any delays in receiving response from unit with respect to work plan Review of collected data for work plan fulfilment Send data to HO for compilation of deficiency response Take follow up with HO to receive updated dossier for product updates Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies Review master validation protocol and report within timeline Check major observation in other units documents also for improvement of validation documents at site Synchronize all units Validation documents for improvement of all units Key Accountabilities (2/6) Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness Collect APQR timely with units for review Review data with supporting documents for data authentication Check major observation with other units for improvement of documents at site Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement Review and compile received technical agreements for comments Provide guidance for execution of batches and handling events as per customer requirement Provide training in department to improve awareness in audit and compliance with licencing department Take follow up with HO for providing fresh TA and pending TAs for products Key Accountabilities (3/6) Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly Receive and check approval certificate, dossiers (TDP & RAP) and development report for distribution at site Update site on receipt of documents for handling execution of customer or market specific batches Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirement to avoid regulatory action and continual improvements Inspect audit prerequisites to support and prepare for external audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Prepare and submit EPA annual production application for getting the establishment registration of unit V Key Accountabilities (4/6) Collect, compile and review raw data and finalise the same for timely submission of MHRA, UK interim update document to corporate as per agency requirement by tracking interim updates at a site level, for risk based inspection planning Coordinate with units for all the raw data, its review and finalization before submission to corporate Prepare pre-inspection compliance report after announcement of MHRA audit Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP Review warning letters received by competitors, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Review audit observations received by other Cipla sites, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Participate in internal team for conducting self-inspection, report preparation, submission and compliance review, to evaluate adherence to cGMP Prepare and update procedures in line with current GMP requirements Key Accountabilities (5/6) Execute on time and errorless submissions by reviewing product license, all certificates for product registration and tender , staff approvals and other applications to adhere to legal requirements Collect, review and finalize applications for: Additional Product COPP Test License Renewal of drugs manufacturing license and WHO GMP certificate All certificates for product registration and tender Alcohol Quota FDA Staff Approval Site Layout Approval Submit and process above application to FDA (district, state, CDSCO) for time bound receipt of approval Communicate with FDA to resolve queries and follow ups to monitor status of application Review, maintain and distribute approved certificates to concerned stakeholders at site Track the consumption of alcohol quota allotted by state FDA under subsidized scheme as per the plan to manage optimum level of alcohol availability for smooth functioning of site Track the status of FDA approved staff at site to adhere to Drug and Cosmetic Act Track the status of quantity specific product license to monitor dispatch of such products and renewal of license in compliance to DCGI NOC condition Key Accountabilities (6/6) Support in CDSCO and state FDA inspection to be GMP compliant and getting product licence, FDA stall approvals by ensuring cross functional interaction Inspect audit prerequisites to support and prepare for CDSCO and state FDA audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Major Challenges Delay in receiving data for allotted work plans from units may impact whole process of deficiency response hence to overcome this situation we are in continue follow up with units for timely response Major observation handling in validation documents impact on registration batch execution, leading to delay in filing of product hence to overcome this situation we share and resolve each observation with units timely with resolving strategy Lack of detailed compliance with appropriate root cause from user department. Regular discussion and trainings is provided to unit Liaising with Government officials for availability and timely approvals of applications Key Interactions (1/2) SPOCs of process validation at site for timely review of master validation protocol and reports at the time document received for review (once or twice a month) SPOCs of APQR at site for timely review of APQR (monthly) SPOCs of RA at site for timely receiving of work plan response of deficiencies on (weekly) Unit QA heads in reference to audit readiness and preliminary draft response (need basis) CQA and A&C team for final draft response review (need basis) Key Interactions (2/2) FDA for processing and approval of application (need basis) Dimensions (1/2) Zero overdue compliance of deficiencies. 100% adherence to provided timelines for review of documents timely. Track and support in Top 07 projects. Timely and errorless review of APQR at site. Review should not exceeding 15 days from schedule. Ensure quality score minimum of 90% for each month. Timely and errorless preparation of tech transfer summary for site. Data submission to corporate should not go beyond 5th of every month Average 30 audits/ year 100% adherence to timeline of compliance for various regulatory and customer audits. No disruption is supply chain because of GMP approvals, product deficiency and product license For FDA: Approximately 150 additional product license 36 test license 40 certificates 290 COPP 5 staff approvals Dimensions (2/2) Key Decisions (1/2) Review observation provided for correctness and improvement of master validation protocol and report documents (To Unit QA) List of pending technical agreements with requirement of fresh TA to HO for regular execution of customer products. Review observation provided for correctness and improvement of APQRs and FDA product license applications at site (To unit QA) Recommend to update correct data provided for deficiency response (To HO) Process of identifying root cause for the observation in various inspection and audit (to CFT) Key Decisions (2/2) Education Qualification B. Pharma/ M.Sc. with minimum three/ four year of experience in quality assurance department Licensing and registration (0-2 years) Relevant Work Experience Sound knowledge of cGMPs and regulatory guidelines and basic knowledge of computer system

Job Title: Internal Audit Analyst Management Level: 11 Analyst Location: Bangalore Must have skills: Chartered Accountant with 2 - 3 years of post-qualification experience in external or internal auditing, preferably in Big 4 or a global organization. Good to have skills: Internal Audit experience with Big 4 or a global organization Job Summary : An agile, highly motivated, innovative thinker with a background in audit, risk, or compliance looking to join a fast-paced, global Internal Audit department that has embraced transformative capabilities including advanced analytics, dynamic risk assessment, and automation to retain its role as a trusted advisor to the business. You are looking to build your career with a leading-edge Internal Audit department that enables you to work with advanced technologies, interact with senior levels of organizational leadership, work with multi-national and multi-cultural teams, participate in professional development activities, and receive global work exposure. Roles & Responsibilities: Participate in the execution of the risk-based audit plan, reporting results to Accenture Leadership and the Audit Committee of the Board of Directors Conduct a wide-ranging scope of audits with an emphasis on assessing emerging areas of risk including revenue recognition, contract accounting, compliance, fraud, operations, and outsourcing. Responsible for end-to-end audit execution including fieldwork, workpaper documentation, leading audit meetings, reporting, and follow-ups; ensuring that methodologies governing internal audits are followed. Leverage the power of advanced data analytics and automation techniques to achieve comprehensive risk coverage and deliver high-quality audit results. Through advisory services, work with our business partners to help them proactively identify and manage risk in new technologies, new go-to-market offerings, and critical corporate initiatives. Shape the future of the Accenture Internal Audit through involvement in operational excellence and best practice initiatives. Ensure technical skill set and business acumen stay current and relevant through participation in our robust training program. Through interaction with clients and team members, develop strong professional relationships that foster trust and collaboration. Keep abreast of company policies and procedures, current developments in accounting and auditing professions. Work with a multinational team and flexibility to work across time zones. Professional & Technical Skills: Chartered Accountant with 2 - 3 years of post-qualification experience in external or internal auditing, preferably in Big 4 or a global organization. Highly motivated and self-driven with limited guidance from the supervisor. Experience in leveraging advanced data analytics in all phases of the audit lifecycle. Excellent project management skills. Strong working knowledge of financial, operational, compliance, and systems auditing techniques. Strong verbal and written communication, report drafting, and presentation skills, and proficiency with the English language. Ability to think outside the box and challenge the status quo. Must be able to work in a dynamic and fast-paced environment with flexibility to adjust to time zones across APAC, Europe, and the U.S. Additional relevant professional or technical certifications (CIA or CFE) is preferred. Readiness for domestic and international travel, as and when required. Additional Information: The ideal candidate will possess a strong educational background along with a proven track record in Internal Audit . This position is based at our Bengaluru office. About Our Company | Accenture Qualification Experience: 2-3 Years of post-qualification experience Educational Qualification: Chartered Accountant

About Us. At SentinelOne, we’re redefining cybersecurity by pushing the limits of what’s possible—leveraging AI-powered, data-driven innovation to stay ahead of tomorrow’s threats.. From building industry-leading products to cultivating an exceptional company culture, our core values guide everything we do. We’re looking for passionate individuals who thrive in collaborative environments and are eager to drive impact. If you’re excited about solving complex challenges in bold, innovative ways, we’d love to connect with you.. What are we looking for?. Reporting to the ManagerInternal Audit, this position is a highly visible and impactful role across the company. The Sr. Analyst – IT Internal Audit, based in India and will work with all levels of management to promote business integrity and robust internal control structures, compliance with Sarbanes-Oxley legislation, and recommendation for process improvements and IT internal Audit projects.. What will you do?. Assist in IT SOX 404 planning, scoping, and risk assessment process through close collaboration with external auditors and business process owners. Engage in Internal audit projects, ERM, operational and IT audits.. Participate in the IT risk assessment process and development of the audit plan for assigned entities. Conduct IT walkthroughs and controls testing according to established audit standards. Develop high-quality process and audit testing documentation for design effectiveness and operating effectiveness of ITGCs, ITAC, SOC1 restricted access controls. Perform testing of application controls, key reports, interfaces, integrations, and segregations of duties rules. Develop and maintain comprehensive documentation including flow charts, process narratives and risk and control matrices and any others required. Evaluate audit findings and coordinate remediation of deficiencies. Strong understanding of US GAAP, SOX requirements, and internal audit standards. Understanding of SDLC principles.. Develop business relationships and proactively interact with process owners to gather information, resolve problems, and make recommendations for improvement and optimization. Demonstrate initiative and provide timely updates to internal audit management. Manage multiple tasks effectively and deliver projects timely. Documentation and activities remain current and in compliance with the IIA’s IPPF Standards and are consistent with best practices. Develop metrics for ongoing operational activities and leverage technology and data analytics to enhance IA operations.. Help manage governance of the Internal Audit function and mature and evolve our audit methodology and operational audit program. Perform other tasks and projects as assigned in support of the internal audit team and corporate objectives. What skills and knowledge should you bring?. Bachelor’s degree in Computer Science, Accounting & Finance, Information Systems, or related field preferred CA/CPA/CISA/CIA/CISSP/CISM. Minimum of 5+ years of audit experience, preferably within the technology industry.. Experience with Big 4 accounting firms or global public companies is strongly preferred.. Ability to take direction, learn quickly, work independently, and maintain a level of professional skepticism. Ability to handle multiple priorities and deadlines, with high standards for quality, accuracy, and attention to detail. Working knowledge of data analysis and business intelligence tools is a plus (PowerBI, Tableau). Data Governance and Management. Business Continuity and Planning and Disaster Recovery. Systems Development Life Cycle (SDLC), Project Management Life Cycle (PMLC), and Application Change Management. Websites and Mobile Applications. IT Asset Lifecycle Management. IT Problem Management, Help Desk and Service Level Management. Enterprise Applications including the following control areas:. Application security architecture. Application access, Server-level access and controls, Database-level access and controls. Why us?. You will be joining a cutting-edge company, where you will tackle extraordinary challenges and work with the very best in the industry.. Industry leading gender-neutral parental leave. Paid Company Holidays. Paid Sick Time. Employee stock purchase program. Disability and life insurance. Employee assistance program. Gym membership reimbursement. Cell phone reimbursement. Numerous company-sponsored events including regular happy hours and team building events. SentinelOne is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.. SentinelOne participates in the E-Verify Program for all U.S. based roles.. Show more Show less

Must have knowledge of documentation (COA, MSDS, VQ Filings , APQR, MOA,DMF) COA/ Certificate of Analysis • MSDS • Specifications/ TDS • Method of Analysis • Stability Data • DMF/ Drug Master File • Declarations Required Candidate profile Intrested Candidate Can share your CV in Whatsapp : 91-9724346949 / 9327657730

Step into the role of Assistant Vice President at Barclays Internal Audit (BIA) in Mumbai, where you'll support the Audit Lead on audit executions to ensure timely and efficient delivery of audit results As an independent contributor, youll support collaborative audit reviews and guide junior team members in the completion of these reviews, You may be assessed on the key critical skills relevant for success in role, such as experience in either Global Markets and/or Corporate Banking business, as well as job-specific skillsets, Basic/ Essential Qualifications Experience in audit and business monitoring, Understanding of relevant regulatory and compliance environment in India, Relevant professional certifications, e-g CIA, CPA, or CISA, is preferred, Job Location is Mumbai, Purpose of the role To support the development of audits aligned to the banks standards and objectives by working collaboratively with colleagues, providing accurate information and recommendations, and complying with policies and procedures, Accountabilities Audit development and delivery support, including financial statements, accounting practices, operational processes, IT systems and risk management, Identification of operational risks to support the delivery of the Barclays Internal Audit (BIA) Audit Plan through risk assessments, Assessment of internal control effectiveness and their capability to identify and mitigate risk aligned to regulatory requirements, Communication of key findings and recommendations to stakeholders, including the Audit Owner, senior managers and directors, Identification of regulatory news and industry trends/developments to provide timely insight and recommendations for best practice, Assistant Vice President Expectations To advise and influence decision making, contribute to policy development and take responsibility for operational effectiveness Collaborate closely with other functions/ business divisions, Lead a team performing complex tasks, using well developed professional knowledge and skills to deliver on work that impacts the whole business function Set objectives and coach employees in pursuit of those objectives, appraisal of performance relative to objectives and determination of reward outcomes If the position has leadership responsibilities, People Leaders are expected to demonstrate a clear set of leadership behaviours to create an environment for colleagues to thrive and deliver to a consistently excellent standard The four LEAD behaviours are: L Listen and be authentic, E Energise and inspire, A Align across the enterprise, D Develop others, OR for an individual contributor, they will lead collaborative assignments and guide team members through structured assignments, identify the need for the inclusion of other areas of specialisation to complete assignments They will identify new directions for assignments and/ or projects, identifying a combination of cross functional methodologies or practices to meet required outcomes, Consult on complex issues; providing advice to People Leaders to support the resolution of escalated issues, Identify ways to mitigate risk and developing new policies/procedures in support of the control and governance agenda, Take ownership for managing risk and strengthening controls in relation to the work done, Perform work that is closely related to that of other areas, which requires understanding of how areas coordinate and contribute to the achievement of the objectives of the organisation sub-function, Collaborate with other areas of work, for business aligned support areas to keep up to speed with business activity and the business strategy, Engage in complex analysis of data from multiple sources of information, internal and external sources such as procedures and practises (in other areas, teams, companies, etc) to solve problems creatively and effectively, Communicate complex information 'Complex' information could include sensitive information or information that is difficult to communicate because of its content or its audience, Influence or convince stakeholders to achieve outcomes, All colleagues will be expected to demonstrate the Barclays Values of Respect, Integrity, Service, Excellence and Stewardship our moral compass, helping us do what we believe is right They will also be expected to demonstrate the Barclays Mindset to Empower, Challenge and Drive the operating manual for how we behave,

Division Department Sub Department 1 Job Purpose Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines Key Accountabilities (1/6) Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner Collect data from all SPOCs with respect to received work plan for review Escalate any delays in receiving response from unit with respect to work plan Review of collected data for work plan fulfilment Send data to HO for compilation of deficiency response Take follow up with HO to receive updated dossier for product updates Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies Review master validation protocol and report within timeline Check major observation in other units documents also for improvement of validation documents at site Synchronize all units Validation documents for improvement of all units Key Accountabilities (2/6) Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness Collect APQR timely with units for review Review data with supporting documents for data authentication Check major observation with other units for improvement of documents at site Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement Review and compile received technical agreements for comments Provide guidance for execution of batches and handling events as per customer requirement Provide training in department to improve awareness in audit and compliance with licencing department Take follow up with HO for providing fresh TA and pending TAs for products Key Accountabilities (3/6) Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly Receive and check approval certificate, dossiers (TDP & RAP) and development report for distribution at site Update site on receipt of documents for handling execution of customer or market specific batches Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirement to avoid regulatory action and continual improvements Inspect audit prerequisites to support and prepare for external audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Prepare and submit EPA annual production application for getting the establishment registration of unit V Key Accountabilities (4/6) Collect, compile and review raw data and finalise the same for timely submission of MHRA, UK interim update document to corporate as per agency requirement by tracking interim updates at a site level, for risk based inspection planning Coordinate with units for all the raw data, its review and finalization before submission to corporate Prepare pre-inspection compliance report after announcement of MHRA audit Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP Review warning letters received by competitors, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Review audit observations received by other Cipla sites, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Participate in internal team for conducting self-inspection, report preparation, submission and compliance review, to evaluate adherence to cGMP Prepare and update procedures in line with current GMP requirements Key Accountabilities (5/6) Execute on time and errorless submissions by reviewing product license, all certificates for product registration and tender , staff approvals and other applications to adhere to legal requirements Collect, review and finalize applications for: Additional Product COPP Test License Renewal of drugs manufacturing license and WHO GMP certificate All certificates for product registration and tender Alcohol Quota FDA Staff Approval Site Layout Approval Submit and process above application to FDA (district, state, CDSCO) for time bound receipt of approval Communicate with FDA to resolve queries and follow ups to monitor status of application Review, maintain and distribute approved certificates to concerned stakeholders at site Track the consumption of alcohol quota allotted by state FDA under subsidized scheme as per the plan to manage optimum level of alcohol availability for smooth functioning of site Track the status of FDA approved staff at site to adhere to Drug and Cosmetic Act Track the status of quantity specific product license to monitor dispatch of such products and renewal of license in compliance to DCGI NOC condition Key Accountabilities (6/6) Support in CDSCO and state FDA inspection to be GMP compliant and getting product licence, FDA stall approvals by ensuring cross functional interaction Inspect audit prerequisites to support and prepare for CDSCO and state FDA audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Major Challenges Delay in receiving data for allotted work plans from units may impact whole process of deficiency response hence to overcome this situation we are in continue follow up with units for timely response Major observation handling in validation documents impact on registration batch execution, leading to delay in filing of product hence to overcome this situation we share and resolve each observation with units timely with resolving strategy Lack of detailed compliance with appropriate root cause from user department. Regular discussion and trainings is provided to unit Liaising with Government officials for availability and timely approvals of applications Key Interactions (1/2) SPOCs of process validation at site for timely review of master validation protocol and reports at the time document received for review (once or twice a month) SPOCs of APQR at site for timely review of APQR (monthly) SPOCs of RA at site for timely receiving of work plan response of deficiencies on (weekly) Unit QA heads in reference to audit readiness and preliminary draft response (need basis) CQA and A&C team for final draft response review (need basis) Key Interactions (2/2) FDA for processing and approval of application (need basis) Dimensions (1/2) Zero overdue compliance of deficiencies. 100% adherence to provided timelines for review of documents timely. Track and support in Top 07 projects. Timely and errorless review of APQR at site. Review should not exceeding 15 days from schedule. Ensure quality score minimum of 90% for each month. Timely and errorless preparation of tech transfer summary for site. Data submission to corporate should not go beyond 5th of every month Average 30 audits/ year 100% adherence to timeline of compliance for various regulatory and customer audits. No disruption is supply chain because of GMP approvals, product deficiency and product license For FDA: Approximately 150 additional product license 36 test license 40 certificates 290 COPP 5 staff approvals Dimensions (2/2) Key Decisions (1/2) Review observation provided for correctness and improvement of master validation protocol and report documents (To Unit QA) List of pending technical agreements with requirement of fresh TA to HO for regular execution of customer products. Review observation provided for correctness and improvement of APQRs and FDA product license applications at site (To unit QA) Recommend to update correct data provided for deficiency response (To HO) Process of identifying root cause for the observation in various inspection and audit (to CFT) Key Decisions (2/2) Education Qualification B. Pharma/ M.Sc. with minimum three/ four year of experience in quality assurance department Licensing and registration (0-2 years) Relevant Work Experience Sound knowledge of cGMPs and regulatory guidelines and basic knowledge of computer system

Senior Internal Auditor India, Chennai Hybrid, Office-Based ICON plc is a world-leading healthcare intelligence and clinical research organization Were proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development, Reporting to the Senior Manager of Internal Audit, you will join a fast paced and dynamic internal audit team supporting ICON's mission to help its clients accelerate the development of drugs and medical devices that save patient lives and improve their quality of life, As a key member of the ICON Group Internal Audit team, you will perform internal control, financial and operational audits for ICON plc, with emphasis on global project governance and risk assurance, What You Will Be Doing Manage various Sarbanes-Oxley (Sox) testing and reporting requirements across ICON's Divisions globally, Lead walkthroughs and risk assessments with process owners Review documentation and assess results to ensure adequate control design and identification of ?key? controls Serve as a main SOX contact for coordination with external auditors related to testing requirements/requests and issues Perform risk based internal audit assignments across ICON's Divisions globally, Consistently evaluate the adequacy and effectiveness of internal controls and compliance, relating to risks across all aspects of ICON, Co-ordinate & deliver quality audit reports containing realistic recommendations, agreed with Management ensuring they are achievable, cost effective and contribute to the business, Play an active role in ensuring any potential operational risk issues and matters, are monitored and communicated effectively, Collaborate with the Senior Manager of Internal Audit on relevant Audit Committee engagements, Analyse large amounts of data in an efficient and accurate manner, using your IT acumen, Familiarise yourself with the In-house SOX tool and look for ways of enhancing its use, Foster good working relationships with global cross-function teams in the business, Promote the Internal Audit brand internally and encourage stakeholders to engage with Internal Audit, Motivate, coach and develop more junior team members to excel in their roles and advance professionally, Your Profile Bachelor's degree in Accounting, Finance, or a related field (Relevant certifications such as CPA, CIA, or CISA are a plus), Must have extensive SOX experience to be considered for this role Big 4 trained preferred 3 years + Audit experience required Post qualification experience in industry preferred Strong Analytical Skills with Good IT Acumen, Strong report writing skills, excellent attention to detail and time management skills What ICON Can Offer You Our success depends on the quality of our people Thats why weve made it a priority to build a diverse culture that rewards high performance and nurtures talent, In addition to your competitive salary, ICON offers a range of additional benefits Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family, Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your familys needs, Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead, Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your familys well-being, Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others, Visit our careers site to read more about the benefits ICON offers, At ICON, inclusion & belonging are fundamental to our culture and values Were dedicated to providing an inclusive and accessible environment for all candidates ICON is committed to providing a workplace free of discrimination and harassment All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status, If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles, Are you a current ICON EmployeePlease click here to apply

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Sr Executive Quality Assurance Job Requisitions No : 13749 Job Description Purpose of Job Preparation and Review of PQR, Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software, Skill Required Having basic knowledge on Microsoft Word and Microsoft Excell Have knowledge of Minitab software for statstical evaluation of data, Roles and Responsibilites Preparation and review of PQR schedule, Planining of PQR compilation as per PQR schedule, Collection of data from all the CFT teams for compilation of PQR, Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software, Based of the PQR data recommendation to be recommended to concern department and ensure implemenation of the same, Qualification Required Pharm or M Relevant Skills / Industry Experience Should have relevant experience in Regulatory approved plant, Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: SEZ, Ahmedabad, GJ, IN, 382213 Travel: 0% 25% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 26 May 2025

About The Role Kotak Mahindra Investments limited (KMIL) is a subsidiary of Kotak Mahindra Bank Limited and is involved in Corporate Real Estate Lending and Structured Finance Business. The KMIL Internal Audit department conducts risk based internal audit (RBIA) for various functions as per the audit plan. Job Role: Performing Internal Audit of Lending business functions and support functions including Compliance, Risk, Secretarial, Accounts, Treasury and Taxation departments as per risk based audit plan. Ability to demonstrate business understanding, assess process, risk and controls and drive improvements. Document audit findings and maintain quality audit paper work. Independently discuss and conclude audit finding with stakeholders Delivering on time quality audit reports Follow up on the recommendations with stakeholders and monitor the compliance for effective closure. Monitor compliance with Industry standards, laws and guidelines Working as a Team Player with a one team mind-set & commercial acumen Collaborating with staff of co-sourcing firms Job requirements: Knowledge about key Regulatory requirements and Internal Policies Professionally qualified CA, CIA would be an added advantage 3 to 8 years of exposure / experience to Internal Audit/ Internal risk control practices of a Financial institution Critical thinking, analytical skills, strong communication, efficient data handling skills High energy, Passion & Self starter attitude with good presentation skills Ability to work under pressure Willing to travel as needed

Physical Walk-in Interview - CQA @ Chennai Role :CQA Experience : 10 years Qualification : BE , Diploma Skills : CQA,8D, SPC, DOE, Audits Interested candidates can share the profile to yamuna.k@harita.co.in

Division Department Sub Department 1 Job Purpose Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines Key Accountabilities (1/6) Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner Collect data from all SPOCs with respect to received work plan for review Escalate any delays in receiving response from unit with respect to work plan Review of collected data for work plan fulfilment Send data to HO for compilation of deficiency response Take follow up with HO to receive updated dossier for product updates Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies Review master validation protocol and report within timeline Check major observation in other units documents also for improvement of validation documents at site Synchronize all units Validation documents for improvement of all units Key Accountabilities (2/6) Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness Collect APQR timely with units for review Review data with supporting documents for data authentication Check major observation with other units for improvement of documents at site Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement Review and compile received technical agreements for comments Provide guidance for execution of batches and handling events as per customer requirement Provide training in department to improve awareness in audit and compliance with licencing department Take follow up with HO for providing fresh TA and pending TAs for products Key Accountabilities (3/6) Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly Receive and check approval certificate, dossiers (TDP & RAP) and development report for distribution at site Update site on receipt of documents for handling execution of customer or market specific batches Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirement to avoid regulatory action and continual improvements Inspect audit prerequisites to support and prepare for external audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Prepare and submit EPA annual production application for getting the establishment registration of unit V Key Accountabilities (4/6) Collect, compile and review raw data and finalise the same for timely submission of MHRA, UK interim update document to corporate as per agency requirement by tracking interim updates at a site level, for risk based inspection planning Coordinate with units for all the raw data, its review and finalization before submission to corporate Prepare pre-inspection compliance report after announcement of MHRA audit Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP Review warning letters received by competitors, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Review audit observations received by other Cipla sites, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Participate in internal team for conducting self-inspection, report preparation, submission and compliance review, to evaluate adherence to cGMP Prepare and update procedures in line with current GMP requirements Key Accountabilities (5/6) Execute on time and errorless submissions by reviewing product license, all certificates for product registration and tender , staff approvals and other applications to adhere to legal requirements Collect, review and finalize applications for: Additional Product COPP Test License Renewal of drugs manufacturing license and WHO GMP certificate All certificates for product registration and tender Alcohol Quota FDA Staff Approval Site Layout Approval Submit and process above application to FDA (district, state, CDSCO) for time bound receipt of approval Communicate with FDA to resolve queries and follow ups to monitor status of application Review, maintain and distribute approved certificates to concerned stakeholders at site Track the consumption of alcohol quota allotted by state FDA under subsidized scheme as per the plan to manage optimum level of alcohol availability for smooth functioning of site Track the status of FDA approved staff at site to adhere to Drug and Cosmetic Act Track the status of quantity specific product license to monitor dispatch of such products and renewal of license in compliance to DCGI NOC condition Key Accountabilities (6/6) Support in CDSCO and state FDA inspection to be GMP compliant and getting product licence, FDA stall approvals by ensuring cross functional interaction Inspect audit prerequisites to support and prepare for CDSCO and state FDA audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Major Challenges Delay in receiving data for allotted work plans from units may impact whole process of deficiency response hence to overcome this situation we are in continue follow up with units for timely response Major observation handling in validation documents impact on registration batch execution, leading to delay in filing of product hence to overcome this situation we share and resolve each observation with units timely with resolving strategy Lack of detailed compliance with appropriate root cause from user department. Regular discussion and trainings is provided to unit Liaising with Government officials for availability and timely approvals of applications Key Interactions (1/2) SPOCs of process validation at site for timely review of master validation protocol and reports at the time document received for review (once or twice a month) SPOCs of APQR at site for timely review of APQR (monthly) SPOCs of RA at site for timely receiving of work plan response of deficiencies on (weekly) Unit QA heads in reference to audit readiness and preliminary draft response (need basis) CQA and A&C team for final draft response review (need basis) Key Interactions (2/2) FDA for processing and approval of application (need basis) Dimensions (1/2) Zero overdue compliance of deficiencies. 100% adherence to provided timelines for review of documents timely. Track and support in Top 07 projects. Timely and errorless review of APQR at site. Review should not exceeding 15 days from schedule. Ensure quality score minimum of 90% for each month. Timely and errorless preparation of tech transfer summary for site. Data submission to corporate should not go beyond 5th of every month Average 30 audits/ year 100% adherence to timeline of compliance for various regulatory and customer audits. No disruption is supply chain because of GMP approvals, product deficiency and product license For FDA: Approximately 150 additional product license 36 test license 40 certificates 290 COPP 5 staff approvals Dimensions (2/2) Key Decisions (1/2) Review observation provided for correctness and improvement of master validation protocol and report documents (To Unit QA) List of pending technical agreements with requirement of fresh TA to HO for regular execution of customer products. Review observation provided for correctness and improvement of APQRs and FDA product license applications at site (To unit QA) Recommend to update correct data provided for deficiency response (To HO) Process of identifying root cause for the observation in various inspection and audit (to CFT) Key Decisions (2/2) Education Qualification B. Pharma/ M.Sc. with minimum three/ four year of experience in quality assurance department Licensing and registration (0-2 years) Relevant Work Experience Sound knowledge of cGMPs and regulatory guidelines and basic knowledge of computer system

Handling & Analysis Of Customer Complaint & 8d (Problem Analysis ,Root Cause Analysis & Preparation Of Counter Measure Action Plan & Submission To Customer Return Rejection First And Last Piece Approval Report Verification Required Candidate profile Monitoring Of Customer Complaint Countermeasure Effectiveness To Participate & Involve In Daily Red Bin Analysis For The Previous Day Rejection & Follow Up Action With Cft SPC & MSA Analysis

Physical walk-in Customer Quality Assurance Date: 16-June-2025 (Monday) to 20-June-2025 (Friday) Time: 4.00 PM 7.00 PM Notice Period: Immediate to 30 Days Venue : Harita Techserv Pvt Ltd 9th Floor, No. 117, Arihant E Park, 1, Lattice Brg Rd, Baktavatsalm Nagar, Adyar, Chennai, Tamil Nadu 600020 (Next to Greater Chennai corporation building) Job Description : Compliance of Customer Specific requirements Compliance of order specifications (or) Technical Specifications Customer Complaints handling- 8D Approach Accurate and on time Response for Customer concern/Queries Validation of Product / Process w.r.t 8D actions Conducting Product audits& Process audits Handle Internal auditing of IATF requirements Ensure Product safety requirements & its implications Cost of Poor Quality (Monitor/Review) Communicate & sensitize customer concerns with Internal stake holders Key Skills: Product Application knowledge Knowledge on 8D, SPC, DOE Process and Product Audits Problem solving techniques Internal auditing of IATF requirements Warranty/NTF Management System Core tools of AIAG Knowledge on IMDS /ROHS /CMRT compliance Knowledge on Product Safety and its Implications GD & T Knowledge If Interested, Please Drop your Profile to deepatharini@harita.co.in

Experience from major pharma industries in Non-oral Products: Topical product and transdermal product. Experience in end-to-end topical product development activities for generic product development ANDA (Cream, ointment, gel, solution, lotion, foam, patch etc.) as well as NDA 505(b)(2), 505(b)(1). Experience in execution of lab scale manufacturing, reverse engineering, analytical know-how, plant level manufacturing activities; scale-up and exhibit batches based on quality principles QbD, QTPP, CQA, CMA, CPP, RA, FMEA. Experienced scientist to perform experiments for development of optimum prototypes (generic, non-infringing composition and robust manufacturing process) with diverse class of drugs & prodrugs (sensitive to pH, acid, base, temperature, oxygen, humidity). Experience in regulatory documentation CMC, MF, BMR, PDR, controlled correspondence for CMC, Biowaiver & Dossier preparation for US-FDA, EU-EMA, AU-TGA & DCGI through successful filing. Experience in working with cross-functional teams (ADD, MSTG, production, QC, QA, RA, IPC, PMO, BD, Microbiology, Pharmacology etc.) to achieve project goals - Filings and subsequent approvals. Knowledge and develop continuous understanding on competitive intelligence, due diligence, US-FDA quality concepts, statistics and global pharma trend analysis to support new product evaluation & introduction. Job Responsibilities: To design, conduct and verify/review experiments to develop a robust formulation . To do literature search, patent search, prepare summary report and review. To prepare product development reports and protocols. To do product scale-up, exhibit batches and prepare reports for product filing and regulatory queries including post filling and post approval market queries. To prepare documents (i.e. PDR, CPD etc.) for regulatory submission Group work co-ordination. Project status report preparation. Experimental result review, interpretation and conclusion. To prepare technology transfer documents. To procure raw materials (API / excipients), packaging materials, innovator samples in consultation with packaging/purchase department. To do product validation, site transfer/change activities of products. To write Laboratory Notebook to enter details related to drug product manufacturing. To prepare test request for analysis of raw materials (API/Excipients) and Drug product.

Job Description Literature search and patent review of products Responsible for formulation development of DPI, SMI pMDIs formulations for US, EU, ROW, CSI and IRF markets. Responsible for planning and execution of development- Pilot / Scale-up and Exhibit activities for pulmonary formulations. Responsible for preparation of timelines, costings for ongoing projects. Responsible for preparation and compilation of project related documents in compliance with quality and regulatory requirements. Responsible for lab maintenance and upkeep of the laboratory and equipment s Responsible for analytical data and interpretation for way forward Responsible for procurement and control of innovators samples and maintaining their records. Responsible for Coordination with planning, engineering department and purchase department for product related activities Responsible for Preparation of department SOPs, guidelines, product related protocols and tech transfer documents along with DQA, CQA and regulatory team. To provide timely support for cross functional activities like regulatory queries, clinical development, technical support to manufacturing plants and intellectual property related inputs and feedback. To provide support for launching and troubleshooting of approved products. Work Experience 12 years + Education Masters in Pharmacy or Pharmacy Doctorate in Pharmacy or Pharmacy Competencies

Understanding of product development related activities of all injectable dosage forms for regulated market. Exposure to injectable dosage form which includes exposure in development of complex injectable products like suspension-based formulation, liposomal formulations, Polymer based products etc. Experienced in preparation and review of product development report, MFR, stability protocol and other study protocols and SOP etc. Basic understanding of implementation of QbD principles for formulation and development (QTPP/CQA/CPP/CMA, risk assessment and control strategy etc.) Effective co-ordination with different departments like regulatory affairs, manufacturing warehouse, quality assurance, quality control and engineering etc. for execution of scale up and exhibit batches.

Job Area: Information Technology Group, Information Technology Group > IT Programmer Analyst General Summary: Qualcomm IT is seeking a Lead Conversational AI Developer for Intelligent Automation Center (IAC)Responsibilities include: Experience on designing and implementing Conversational AI solutions using Microsoft Azure and Copilot Stack in combination with GenAI Hands-on experience with Microsoft Copilot Studio, Microsoft Bot Framework, NLP, Azure AI Search and Azure OpenAI Extensive hands-on experience in implementing end-to-end projects utilizing Generative AI using Retrieval-Augmented Generation (RAG) or Agentic AI architecture Strong expertise in Python for building bot solutions Experience with Azure Cognitive Services (LUIS/CLU, QnA Maker/CQA, Spell Check,Speech API) for advanced NLP features. Knowledge of Power Automate, Azure Logic Apps, and APIs for extending Copilot Agent and bot functionalities. Experience in software development with a focus on Conversational AI and Machine Learning. Proficiency with tools and Frameworks such as LangChain, LlamaIndex, and Streamlit. Knowledge and implementation experience of chatbot technologies using Microsoft Azure Services and Power Platform. Ensure quality of coded components by performing thorough unit testing and develop reusable test cases Work collaboratively with test teams for supporting Product testing and UAT Report status, issues and risks to tech leads on a regular basis Improve skills in automation products through certifications Train and coach team members on Conversational AI related technologies Work independently with minimal supervision and good team management skills Excellent communication and collaboration skills Provide timely status on assignments, planned activities, issues, and dependencies Good knowledge on Conversational AI on Microsoft Stack (Copilot Studio, Azure AI Foundry, Azure AI Search, Azure OpenAI) Good understanding of Generative AI concepts and Frameworks like Langchain Hands-on programming experience on Python and any frontend technology like Angular Minimum Qualifications: 4+ years of work experience in programming, scripting, and/or automation or IT-relevant work experience with a Bachelor's degree. OR 6+ years of work experience in programming, scripting, and/or automation or IT-relevant work experience without a Bachelors degree. 2+ years experience with Database Design structures such as Mongo DB, MySQL. Good understanding of conversational AI and Intelligent Automation methodologies and associated tools & technologies Knowledge of Process Mining concepts and implementation expereience using Celonis inclusing data models and dasboards Experience in business process diagrams and process flow charts with Automation Anywhere Certification in Industry Leading Robotic Automation products is a plus. Experience in identifying the right processes for Automation and providing estimates for implementations Programming concepts and coding background in Python Understanding of RDBMS concepts and writing SQL queries Expereience in Cloud (preferrably AWS) and certifications is a plus Experience in Agile development using standard tools like Jira Bachelor's degree and 5+ years IT-relevant work experience

Job Area: Finance & Accounting Group, Finance & Accounting Group > Internal Audit General Summary: Auditor, IT Internal Audit- Hyderabad Qualcomm is a company of inventors that unlocked 5G - ushering in an age of rapid acceleration in connectivity and new possibilities that will transform industries, create jobs, and enrich lives. But this is just the beginning. It takes inventive minds with diverse skills, backgrounds, and cultures to transform 5Gs potential into world-changing technologies and products. This is the Invention Age - and this is where you come in. This is a unique opportunity to join Qualcomms finance and accounting organization based in Hyderabad in the Corporate Internal Audit & Advisory Services (IA & AS) team. The department focuses on assisting the Audit Committee and management teams in the improvement of processes that manage risks related to achieving Qualcomms business objectives. Using Qualcomms risk-based audit methodology, the IT auditor will assist in the execution of internal audits. Specifically, the responsibilities include: Providing U.S. based time zone coverage as needed (up to 50% of time) Supporting the creation of initial planning memos and process flowcharts Identifying and assessing initial risks and control activities Designing audit procedures to evaluate control effectiveness Performing audit testing, identifying deviations from expected control activities, and effectively communicating observations to the audit team Leveraging data analytics throughout the audit process where feasible Staying abreast of changes in the business and industry to assess impacts to the companys risk profile Contributing to the development of new concepts, techniques, and making continuous process improvements for the overall IA team All Qualcomm employees are expected to actively support diversity on their teams, and in the Company. One to three years of relevant experience in internal auditing, external auditing, or SOX compliance within a global public company (preferably in the high-tech industry), Big 4/mid-tier accounting firm or other fast-paced corporate setting Strong understanding of IT general controls, cybersecurity frameworks (e.g. NIST, COBIT), and ERP systems Fluent English; multi-lingual capability is a plus Successful candidate will possess the following characteristics: As feasible, ability to travel (infrequently) to Qualcomms domestic and international locations (e.g., U.S., Europe) Semiconductor business experience or familiarity Strong communication (oral and written) and presentation skills Fast learner with strong interpersonal, organization, analytical, critical thinking, and problem-solving skills Ability to work in a flexible and non-hierarchical team environment Willingness to get things done and take responsibility Ability to recognize and apply a sense of urgency, when necessary Comfortable with ambiguity Positive attitude, professional maturity, good work ethic Ability to work independently, handle multiple projects simultaneously and multi-task to meet deadlines with high-quality deliverables Controls, risk assessment, risks, internal audit, IT Bachelor's degree in Accounting, Finance, Computer Science, cyber security, or related field. CPA, CA, CIA, CISA, CFE, or other credentials, a plus. Minimum Qualifications: Bachelor's degree. 1+ year of Finance, Accounting, or related work experience. *Completed advanced degree in a relevant field may be substituted for up to one year (Masters = one year) of work experience.

Job Area: Finance & Accounting Group, Finance & Accounting Group > Internal Audit General Summary: Job Overview Qualcomm is a company of inventors that unlocked 5G - ushering in an age of rapid acceleration in connectivity and new possibilities that will transform industries, create jobs, and enrich lives. But this is just the beginning. It takes inventive minds with diverse skills, backgrounds, and cultures to transform 5Gs potential into world-changing technologies and products. This is the Invention Age - and this is where you come in. This is a unique opportunity to join Qualcomms finance and accounting organization based in Hyderabad in the Corporate Internal Audit & Advisory Services (IA & AS) team. The department focuses on assisting the Audit Committee and management teams in the improvement of processes that manage risks related to achieving Qualcomms business objectives. Using Qualcomms risk-based audit methodology, the senior auditor will assist in the execution of internal audits. Specifically, the responsibilities include: Providing U.S. based time zone coverage as needed (up to 50% of time) Supporting the creation of initial planning memos and process flowcharts Identifying and assessing initial risks and control activities Designing audit procedures to evaluate control effectiveness Performing audit testing, identifying deviations from expected control activities, and effectively communicating observations to the audit team Leveraging data analytics throughout the audit process where feasible Staying abreast of changes in business and industry to assess impacts on the companys risk profile Contributing to the development of new concepts, techniques, and making continuous process improvements for the overall IA team All Qualcomm employees are expected to actively support diversity in their teams, and in the Company. Minimum Qualifications Three to Five years of relevant experience in internal auditing, external auditing, or SOX compliance within a global public company (preferably in the high-tech industry), Big 4/mid-tier accounting firm or other fast-paced corporate setting Fluent English; multi-lingual capability is a plus Preferred Qualifications Successful candidate will possess the following characteristics: As feasible, ability to travel (infrequently) to Qualcomms domestic and international locations (e.g., U.S., Europe) Semiconductor business experience or familiarity Strong communication (oral and written) and presentation skills Fast learner with strong interpersonal, organization, analytical, critical thinking, and problem-solving skills Ability to work in a flexible and non-hierarchical team environment Willingness to get things done and take responsibility Ability to recognize and apply a sense of urgency, when necessary Comfortable with ambiguity Positive attitude, professional maturity, good work ethic Ability to work independently, handle multiple projects simultaneously and multi-task to meet deadlines with high-quality deliverables Keywords controls, risk assessment, risks, internal audit, SOX Educational Bachelors degree in accounting, Finance, Business Administration, or related field. CPA, CA, CIA, CFE, or other credentials, a plus. Minimum Qualifications: Bachelor's degree. 3+ years of Finance, Accounting, or related work experience. *Completed advanced degrees in a relevant field may be substituted for up to two years (Masters = one year, Doctorate = two years) of work experience. Job Overview Qualcomm is a company of inventors that unlocked 5G - ushering in an age of rapid acceleration in connectivity and new possibilities that will transform industries, create jobs, and enrich lives. But this is just the beginning. It takes inventive minds with diverse skills, backgrounds, and cultures to transform 5Gs potential into world-changing technologies and products. This is the Invention Age - and this is where you come in. This is a unique opportunity to join Qualcomms finance and accounting organization based in Hyderabad in the Corporate Internal Audit & Advisory Services (IA & AS) team. The department focuses on assisting the Audit Committee and management teams in the improvement of processes that manage risks related to achieving Qualcomms business objectives. Using Qualcomms risk-based audit methodology, the senior auditor will assist in the execution of internal audits. Specifically, the responsibilities include: Providing U.S. based time zone coverage as needed (up to 50% of time) Supporting the creation of initial planning memos and process flowcharts Identifying and assessing initial risks and control activities Designing audit procedures to evaluate control effectiveness Performing audit testing, identifying deviations from expected control activities, and effectively communicating observations to the audit team Leveraging data analytics throughout the audit process where feasible Staying abreast of changes in business and industry to assess impacts on the companys risk profile Contributing to the development of new concepts, techniques, and making continuous process improvements for the overall IA team All Qualcomm employees are expected to actively support diversity in their teams, and in the Company. Minimum Qualifications Three to Five years of relevant experience in internal auditing, external auditing, or SOX compliance within a global public company (preferably in the high-tech industry), Big 4/mid-tier accounting firm or other fast-paced corporate setting Fluent English; multi-lingual capability is a plus Preferred Qualifications Successful candidate will possess the following characteristics: As feasible, ability to travel (infrequently) to Qualcomms domestic and international locations (e.g., U.S., Europe) Semiconductor business experience or familiarity Strong communication (oral and written) and presentation skills Fast learner with strong interpersonal, organization, analytical, critical thinking, and problem-solving skills Ability to work in a flexible and non-hierarchical team environment Willingness to get things done and take responsibility Ability to recognize and apply a sense of urgency, when necessary Comfortable with ambiguity Positive attitude, professional maturity, good work ethic Ability to work independently, handle multiple projects simultaneously and multi-task to meet deadlines with high-quality deliverables Keywords controls, risk assessment, risks, internal audit, SOX Educational Bachelors degree in accounting, Finance, Business Administration, or related field. CPA, CA, CIA, CFE, or other credentials, a plus.

Role & responsibilities Quality Strategy & Compliance - Develop and implement quality policies, procedures, and standards aligned with ISO 9001, IATF 16949, OSHAS, ISO 14001 and Exposure to IRIS & AS 9100 D / NADCAP. / Other OEM requirements. - Ensure adherence to welding standards EN ISO 3834-2, EN ISO 15085-2 CL1,and heat exchanger specifications (e.g., ASME, TEMA). - Monitor compliance with health, safety, and environmental regulations (OSHAS / ISO 14001). Team Leadership - Manage a team of QC inspectors, engineers, and technicians. - Foster a culture of quality through training, mentoring, and performance evaluation. . Process & Product Oversight - Oversee inspection/testing of aluminium components using tools like CMM, X-ray, ultrasonic testing, and dye penetrant. - Conduct root cause analysis (RCA) for defects and implement corrective actions (CAPA). - Lead cross-functional collaboration with Production, R&D, and Engineering to embed quality in design (APQP, FMEA, PPAP). Audits & Supplier Management - Execute internal/external audits and manage customer/supplier audits. - Evaluate supplier quality through audits, performance reviews, ratings and material certifications. 5. Data Analysis & Reporting - Track KPIs (scrap rates, defect rates, customer returns) using statistical tools (7 QC Tools or Minitab, SPC, SQC). - Report to senior management on quality performance and improvement initiatives. Continuous Improvement - Drive Lean Manufacturing, Six Sigma, or Kaizen projects to reduce waste and enhance efficiency. - Stay updated on industry trends (e.g., automation in welding, advanced NDT methods). Preferred candidate profile Educational Qualifications - Education: BE/B.Tech ; ME/M.Tech in Metallurgical, Mechanical, or Industrial Engineering. - Experience: 10+ years in quality control, with 5+ years in *automotive manufacturing* and expertise in *aluminium welding/heat exchangers*. - Certifications: CQE, CQA, Six Sigma (Green/Black Belt), IATF 16949 Lead Auditor. - Technical Skills: - Proficiency in QMS software (e.g., SAP QM, IQMS). - Knowledge of APQP, PPAP, FMEA, and Control Plans. - Understanding of aluminium metallurgy and welding challenges (e.g., porosity, cracks). Perks and benefits

JOB DESCRIPTION Job Title: Qualification/Validation Team Lead Job Location: Syngene International Limited, Bengaluru About Syngene : Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory training related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Core Purpose of the Role: This is an exciting opportunity to play a role in Corporate Quality Assurance of Syngene. The role will provide exposure to bring in newer technologies. It provides an opportunity to think ahead of time and be prepared to take up newer challenges. Role Accountabilities Responsible to monitor the health of Qualification/validation process and for the continuous improvement as per current regulatory expectation. Review/Approval of Qualification, Validation, Re-qualification documents and QMS activities in compliance to approved procedures. Identify, coach and monitor the team developments and improvements activities. Ensure compliance with the observations of an internal, client, or regulatory audit and provide response or support for observation related CQA function. Drive operational excellence projects for continuous improvement. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience Demonstrated Capability Education Experience 12-15 years of experience in Biopharmaceutical drug substances and drug products industry. Handson experience for handling qualification of the equipment used in manufacturing Biopharmaceutical drug substances and drug products. Deep knowledge of qualifications of HVAC, LAFs, Biosafety Cabinets, autoclaves. Understanding of Temperature mapping. Taken up green belt six sigma projects. Skills and Capabilities Expertise in handling qualifications and validations of Biopharmaceutical equipment. Capable of thinking scientifically to address complex problems and develop solutions Work as a team and have a collaborative mindset. Good communication skills Education M.Sc/B.E with thorough knowledge Equipment qualification and validation. Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

JOB TITLE: Skin Care Packaging Specialist, India BU JOB FUNCTION: Research and Development REPORTS TO: Skincare Packaging Excellence Leader, South Asia BU CATEGORY GLOBAL / CATEGORY CLUSTER / GLOBAL PACKAGING: Cluster Packaging WORK LOCATION: Mumbai HURC BUSINESS CONTEXT AND MAIN CHALLENGES OF THE JOB: Unilever recognises Packaging as an important part of the product mix. Not only does it fulfil a very important functional role, to contain, protect and inform, but also as the first touchpoint with the consumer, it must engage the consumer, reflecting the brand proposition, and delivering a delightful experience. To ensure the robustness and technical performance of new packaging, before it is placed in the market, involves both design and technical innovation in packaging. Working closely with other Unilever functions as part of a cross-functional team, the Packaging specialist will support Packaging Manager with the co-ordination of packaging development projects and can lead assigned projects as packaging work stream leader by developing and executing testing plans for primary and secondary packaging, ensuring packaging is fit for purpose compatible with SC, Formulation, Unilever Policy, Consumer and Brand needs and legislation. Testing plans can include laboratory tests (at Unilever, at our convertors, and at 3rd party labs), factory trials, and distribution trials. The jobholder is expected to maximize the use of design tools and deliver projects using Unilever project tools. In addition to planning and executing a range of comprehensive technical validation tests, the jobholder is expected to interpret results, prepare reports and communicate results/recommendations to the multifunctional project team to deliver the packaging activities. This position will interface with Brand Development, Supply Chain, Procurement, Product development, Processing, CTI, CMI, and Packaging Suppliers, to drive consumer focused innovative and optimized packaging solutions. MAIN ACCOUNTABILITIES : Deliver packaging which not only meets the required quality and technical standards, but also delights the consumer and builds brand love, through using Unilever s Packaging Excellence best practices. Few of the brands which candidate will be closely associated is Ponds Talc, Ponds Cold Cream and H&B. Collaborating with cross functional team and suppliers to generate VPR (PCR and APR) capabilities for Skin care. Lead its execution while ensuring alignment with the Global packaging team on simplification and harmonization. Lead and execute projects for SA ensuring FTR OTIF delivery, by closely working with Global Packaging Team, Formulation team, SUIT, CQA, Marketing and suppliers. Provide early inputs to the Global packaging team - considering the capability, constraints and expectations for SA. Liaise with packaging converters and material suppliers in the development of packaging components. Manage assigned primary and secondary packaging projects with guidance, working with Brand Development and the cross-functional project team, ensuring packaging is fit for purpose to meet the packaging brief, and delivered on time, in full. Evaluate and qualify packaging components for their project portfolio using both established protocols, and where appropriate, design new ones by closely working with Global Teams. Perform technical analysis of new packaging designs and provision of feedback to project teams with respect to design viability; also, identify possible solutions to resolve technical problems, minimizing changes to the design intent. To manage good technical data records - project data, specifications, test results Where relevant, to deliver, as a member of a cross-functional project team, solutions to agreed projects, on time in full. Prepare and develop supplier technical briefs where required, working closely with suppliers. To interface with other functions in support of project delivery (e. g. brand development, supply chain, procurement) To manage and deliver agreed work plan. To develop and test packaging in accordance with the One Unilever Packaging Process (1UPP) To comply with the Unilever Code of Business Principles and all Safety, Health and Environment (SHE) and Quality Assurance (QA) policies, including the support of product claims, risk management. Key Competencies: Bias for action Accountability & Responsibility Growth Mindset Consumer & Customer focus Building Talent & Teams Key Skills: Working knowledge on a range of packaging materials - Flexibles, Rigid & Paper/paperboard packaging. Sustainability programme. Able to work effectively in multi-disciplinary, multi-cultural teams. Technical specification & supply chain support. Project management experience Basic appreciation on polymers, molds and decoration techniques are appreciated. Refer the details. Understanding for Rigid packaging and understanding of IM/EBM/IBM technologies. Understanding of Film Resin grades and its supply base, cost dynamics. Understanding on value chain of flexibles, Rigid packaging. Understanding of Machine - Packaging Material interface Understanding on Mould and component qualification Relevant Experience: Education- Post Graduation in Packaging Technology, BTech/MTech in Packaging Technology, Polymer or Chemical technology. Min. 1 to 4 yrs experience. Working knowledge of Flexibles, Rigid & Paper/paperboard packaging Added advantage- Experience in Personal care packaging Project Execution Understanding on Design principles Any other critical personal characteristics: Candidate should be creative in personal care characteristics, have design mindset, external orientation, appetite to explore new ideas across format like rigids and flexibles etc and ability to work with diverse people/functions across geographies. Able to work effectively in multi-disciplinary & multi-cultural teams. Willingness to support global WoW with time zone differences. Flexibility in work style to be able to manage several projects simultaneously. Intermediate to Advanced Intermediate Level English (person must be able to write emails and reports in English, which can be easily understood, and can actively participate at English-speaking business meetings). Must effectively communicate on technical issues with other technical personnel and nontechnical personnel and management orally and in writing Excellent influencing ability, both internal as well as external Demonstrated ability to manage senior stakeholder relationship. Good communication skills Occasional travel: 1 - 10 days (Domestic) Our commitment to Equality, Diversity & Inclusion Unilever embraces diversity and encourages applicants from all walks of life! This means giving full and fair consideration to all applicants and continuing development of all employees regardless of age, disability, gender reassignment, race, religion or belief, sex, sexual orientation, marriage and civil partnership, and pregnancy and maternity.

Preparation of APQR, review of documents and records. Supporting to Customer complaint & assistance in implementation of CAPA. To assist in maintaining Food safety & Quality management system. To review HACCP verification & validation plan, adhere to FSSAI requirements for the food premixes division and comply with the requirements of various regulatory authorities and customers. To review SOPs, batch manufacturing and packing records, specifications and test methods of the products. Handling of deviations, change controls, out of specifications may occur at all stages of storage, dispensing, manufacturing, packing, testing and distribution. To ensure issuance, control, distribution, storage, retention and destruction of quality documents and corporate guidelines as per Food safety & Quality management system. To assist in compliance to the current ISO 9001, D&C Act, FSS Act 2006, FSSC 22000, FAMI-QS, WHO-GMP, UNICEF and other customer and regulatory requirements. Reporting of daily non-conformance, online deviation if any. Preparation and updation of Q.A departmental SOP s and loading it in DCS (Document Control System) ENSUR, Change control in trackwise and handling of SAP system. To assist in an audit and compliance process. To provide necessary documents required by CQA and other customers. Co-ordination with marketing Representative in responding customer queries and submitting Questionnaire as per customer requirement. Execution of requirements for food/Dietary supplements regulations for export market (US)-21 CFR Part 111. Ensuring avoidance of breach of data integrity in area. Imparting necessary assistance to shop floor personnel. Adherence to the requirements of EHS norms. Execution of various initiatives as are suggested by corporate functions (SEEDS, Learning University, Quality mindset). Customer / Patient centricity. Document Archival. To assist in effective Hygiene and sanitation program in area. Execution of various initiatives as are suggested by corporate functions. To determine internal and external QEHS issues as well as needs and expectations of relevant interested parties and monitor the same. To implement QEHS policy & objectives. To ensure participation and consultation of worker. Ensure use of PPE To identify & communicate incidents, QEHS nonconformities, investigate and take corrective actions on the same. To ensure work permit system during maintenance activities. To implement QEHS continual improvement projects at site and monitor. To ensure disposal of waste. Authorized to prevent improper workplace conditions. Authorized for reporting of Hazards, Incident, Accidents and Near miss reporting. Authorized to prepare OH&S performance document. Authorized to conduct training of workmen related to OHSMS. Insuring shade cards and artwork Preparation and review of quality risk assessments MSC / B. Tech food Technology

LVP Production Job Description Followings will be the core Job Responsibilities of the position holder: Compliance to laid standards of the current good manufacturing practices. Carrying, review and approval of Qualification of Production equipment. Compliance to specifications and validated methods. Training and evaluation of the Management and Non-Management persons for their qualification to specific task or to operate specific equipment. Preparation, review and approval of Standard Operating Procedures, for related equipments and procedures. Raising, review of requisition for the requirements of consumables items and check on its inventories according to their approved budget. Implementation of Quality Management System as per cGMP and international requirement at all levels of Manufacturing. Corrective and Preventive actions implementation for observed non-conformance & self inspection points. To exercise effective control over the environmental conditions in Manufacturing and other related activities, which may adversely affect the product quality. To co-ordinate and approve the calibration / preventive maintenance for all production equipments and instruments with engineering / QA / QC & outside agencies. To carry out routine documentation as per Regulatory Requirements. To work within the specified working hours. To ensure maintenance of production area and equipments in the state of cleanliness as per the SOPs at all points of time. Coordination with PPIC, QC, CQA, PLM, QA and other cross functional departments for smooth production activities. Organizing the job responsibilities to the technicians, officers, executives, assistant managers as per plan & control on absenteeism. Verification of input materials against plan and its checking as per process work orders To ensure continuous process improvisation in all production areas. Continuous monitoring and improving the production output on daily basis. To fill and maintain and approve the BPR/ BMR online and to ensure online entries in SAP. To evaluate and sign the production records before they are sent to the QA department. To maintain /fill and review the formats of Production and other related documents. Monitoring and Control of manpower utilization, yield, waste data and Opex. To ensure compliance w.r.t. regulatory agencies and ensure all-time audit readiness. Handling of online systems and software and ensure review and approval in systems such as SolTRAQs, ISOtrain, Darius, Brainshark, Harmony etc. Ensure the compliance of SAP activities related to updation of BOM, creation of new items codes, batch transactions etc. for smooth production activities. To ensure the compliance BBS and BBQ in the area. To conduct the Self-inspection/ internal audit as per site Internal Audit Program. To investigate and provide CAPA for self-inspection/ internal audit and external audit observation. To conduct cGMP and GDP training of employees in LVP facility. t SIGNIFICANT WORK ACTIVITIES: Keyboard use (greater or equal to 50% of the workday)

Job Title - Internal Audit Manager Management Level :07 - Manager Location:Bangalore Must have skills:Chartered Accountant with Internal or external audit experience Good to have skills:Certifications - CIA or CFE Experience: Minimum 8 years of experience is required Educational Qualification: Chartered Accountant Job Summary : As the Internal Audit Manager at Accenture, you will develop and implement a risk-based audit plan, conduct audits in emerging risk areas such as revenue recognition, contract accounting, compliance, fraud, operations, and outsourcing, and report findings to leadership and the Audit Committee. This role entails overseeing all audit processes, leveraging data analytics and automation for comprehensive risk coverage, and providing advisory services to help business partners manage risks in new technologies, market offerings, and corporate initiatives. You will participate in operational excellence initiatives, maintain current technical skills through training, foster trust and collaboration with clients and team members, stay updated on company policies and industry developments, and supervise a multinational team across various time zones. Roles & Responsibilities: Participate in the creation and execution of the risk-based audit plan, reporting results to Accenture Leadership and the Audit Committee of the Board of Directors. Conduct a wide-ranging scope of audits with an emphasis on assessing emerging areas of risk including revenue recognition, contract accounting, compliance, fraud, operations and outsourcing. Responsible for end-to-end audit oversight including scoping, staffing, planning, fieldwork, workpaper documentation, leading audit meetings, reporting, and follow-ups; ensuring that methodologies governing internal audits are followed. Leverage the power of advanced data analytics and automation techniques to achieve comprehensive risk coverage and deliver high-quality audit results. Through advisory services, work with our business partners to help them proactively identify and manage risk in new technologies, new go-to-market offerings, and critical corporate initiatives. Shape the future of the Accenture Internal Audit through involvement in operational excellence and best practice initiatives. Ensure technical skill set and business acumen stay current and relevant through participation in our robust training program. Through interaction with clients and team members, develop strong professional relationships that foster trust and collaboration and, as a leader, set a solid example for the staff. Keep abreast of company policies and procedures, current developments in accounting and auditing professions. Supervise and work with a multinational team and flexibility to work across time zones. Professional & Technical Skills: Chartered Accountant with 8 - 10 years of post-qualification experience in external or internal auditing, preferably in Big 4 or a global organization. Highly motivated and self-driven with limited guidance from the supervisor and provides appropriate direction to the Internal Audit staff. Experience in leveraging advanced data analytics in all phases of the audit lifecycle. Excellent people management, mentoring, and project management skills. Strong working knowledge of financial, operational, compliance, and systems auditing techniques. Strong verbal and written communication, report drafting, and presentation skills, and proficiency with the English language. Ability to think outside the box and challenge the status quo. Must be able to work in a dynamic and fast-paced environment with flexibility to adjust to time zones. Additional relevant professional or technical certifications (CIA or CFE) is preferred. Readiness for domestic and international travel, as and when required. Additional Information: This position is based at our Bengaluru office. About Our Company | AccentureQualification Experience: Minimum 8 years of experience is required Educational Qualification: Chartered Accountant