470 Quality Systems Jobs - Page 18

DesignationSenior Quality Engineer Full Time Opportunity LocationFull Time Opportunity : - Maintain Plant-level Quality Culture and Quality System - Ensure compliance to ISO 9001 requirements - Conduct In-process and Final Inspections as per protocol - Ensure timely competence assessment of the Production team through Skill Mapping - Provide training & development to Production Team as per requirement to increase level of competence, productivity, quality - Drive continuous improvement of processes through systematic implementation of Kaizen - Identify NCs in Quality Management System and initiate corrective actions - Ensure compliance to National and International standards (BIS CRS, ENEC, CB, CE, RoHS) - Ensure product labelling match product specifications and applicable statutory and regulatory requirements - To monitor and direct day to day process development to ensure product quality, timely product shipments, continuing cost effectiveness and profitability - Improve operational quality results by studying, evaluating, and recommending process re-design; implementing changes; contributing information and opinion to unit design and modification of teams. - Maintain and improve product quality by timely investigation of customer complaints and completing product & quality system audits Required Skills: - Should have worked in Quality function in a similar capacity - Should have strong experience in problem solving tools - Should have knowledge in areas like Six Sigma, Lean and 5S - Should possess adequate Business Acumen - Should be a self-starter & a quick learner - Should be an excellent team worker - Should possess excellent communication skills This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

Knowledge of preparation of BMR, BPR, MFR, SMP, Change control, Deviation. Develop and implement quality assurance system Oversee quality control process Conduct internal audits & inspections Ensure laboratory compliance with regulatory requirements Required Candidate profile Bachelor's degree in a relevant scientific field like B.Pharma, M.Pharma, B.Sc Previous experience in quality assurance in laboratory setting or an API Mfg company Min 5 years of experience required

Lead, support, and report independent GCP/PV audits according to the Novartis Quality Systems and the current GCP/PV regulations to assess compliance with applicable regulations, standards, and guidance documents. Review and approve corrective action plans in support of the audit observations. Ensure alignment with the companys strategic direction and assist in driving the implementation of the applicable actions. Provide consultation to NVS business units through risk-based assessments. Act as SME for assigned areas of responsibility. Key Responsibilities: Support the strategic development of an effective global risk-based audit strategy and program; collect, collate, and incorporate input into audit strategy and plan. Lead, plan, conduct, document, and follow-up of global quality regulatory compliance audits and assessments of GCP/GPvP according to the requirements specified in the respective Novartis Quality Module as we'll as applicable regulations, standards, quality agreements, and guidance documents. Perform activities with a high degree of independence. Provide technical guidance, leadership, mentoring, and training of other Auditors on audit-related activities. Prepare audit reports, according to NVS requirements and timelines. Ensure appropriate escalation to responsible management in case of critical audit findings and support immediate follow-up measures according to the Novartis requirements on Management Escalations and other relevant procedures. Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP) Identify and communicate quality and regulatory compliance issues to quality management through appropriate channels as we'll as recommend remediations. Lead compliance investigations and initiatives focused on inspection readiness and quality, process, and compliance improvement as requested. Support mock pre-approval inspections (PAIs) and HA inspections as needed. Proactively research local and global initiatives, trends, and events that impact the maintenance of compliance. Mentor GCP/PV staff as required. Complete any other request from global GCP Audit. Review and approve audit reports as required and also participate in the Lead Auditor program. Essential Requirements: 15+ years of proven experience in GCP / GPvP / clinical / industry / health authority experience or equivalent. 8+ years of GCP/PV auditing experience preferred and willingness to travel up to 60% of the time. Ability to lead and objectively evaluate compliance issues. Ability to address a variety of tasks within the same timeframe while maintaining oversight; maintain a moderate degree of independence with respect to decision-making and problem-solving. Experience with Health Authority inspections and interactions preferred. Good quality and compliance leadership and facilitation skills. Excellent verbal and written communication, organizational, and interpersonal skills. Excellent computer skills including Excel, MS Office, etc Extensive knowledge of applicable GCP, PV, and GxP regulations, guidelines, policies, and procedures. Good knowledge of CSV and 21 CFR Part 11, ability to lead audit teams, and operate successfully in various team capacities. Excellent leadership and facilitation skills, Auditor certification desirable. Desirable Requirements: Graduate in natural/biological sciences or equivalent, or an equivalent mix of education and experience

BACKGROUND . Over its 15 years of existence, THF has reached more than 35 million beneficiaries through its programs. THF works with communities through direct implementation of projects on the ground in addition to providing local management and monitoring support to not-for-profit organisations in India funded through THF USA and RIST. PROJECT OVERVIEW: PHC Assam (Amarpur, Assam) The Primary Health Centre Project in Assam, supported by The Hans Foundation, is an initiative aimed at strengthening primary healthcare delivery in rural and underserved regions of the state. Amarpur PHC in Tinsukia district is being adopted by THF in Assam. The centre will provide comprehensive primary healthcare services, including maternal and child health, non-communicable disease screening, mental health support, and health promotion. The PHC will be staffed by a Medical Officer, GNM, ANM, Lab Tech, Data Entry Operator, Pharmacist and other support staff, equipped with necessary medical equipment, diagnostic kits, and IT infrastructure for telemedicine and reporting. GENERAL Location of Job: Amarpur, Assam Annual Salary : Salary will commensurate with education, experience of the candidate and past salary drawn. No. of positions: 1 1. JOB PURPOSE The Medical Officer will be responsible for medical check-ups of the serving community through duties at PHCs following the visit roster, treating and providing consultation to the patients and maintaining. The Medical Officer will analyze medical check-up data and conduct regular inspection of equipments, maintaining the inventory of medicine required at PHC. S/he ensure compliance of the requirements and protocols as per Govt Rules. S/he will present the data to management and make suitable action plan. 2. KEY ACCOUNTABILITIES Conduct camp duties as per visit roster and perform medical check-ups of the serving community. Supervise and ensures the availability of inventory and supplies of drugs, reagents and equipment as required at PHC. Conduct home visits for elderly/ severely sick patients and persons with disabilities. Collaborate with other specialists and health facilities for timely, right referral of required cases. Analyse medical check-up data of the patients and provide counselling sessions as required. Management of the team and their capacity building. Ensuring optimum utilisation of available resources of the PHC. Maintain the confidentiality of the patient data and adhere the IPHS/IMC protocols for the treatment. Adhere and ensure implementation enforcement of Protocol/Quality systems. Ensure that documents like OPD, medicines and reagents consumption, patients cards etc. are updated and maintained regularly. Inspect the requisition and viability of medical equipment instrument at the PHC. Create awareness on health topics by participating in campaigns organized through PHC. Share the success stories/anecdotes from the field. Prepare trends of communicable and non-communicable diseases. Attend the periodic review meeting organized by THF team. Any other duties that may be assigned from time to time by the THF management. 3. Reporting to : Project Coordinator/ Project Manager 4. Other Indicative Requirements Educational Qualifications: MBBS Functional / Technical Skills and Relevant Experience Other requirements (Behavioural, Language, Certifications etc.) Minimum of 1-5 years of experience in public health programs with good team management skills. Candidate must have good communication skills in Hindi. Should be registered with National Medical Council.

Job Title Design Quality Engineer Job Description Job title: Design Quality Engineer - Medical Devices The Design Quality Engineer DQE provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. The DQE also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes Your role: Ensure appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design. Validate key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability, and costs. Provide effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle. Perform independent technical assessment on product quality performance and post market product quality analysis. Can Lead quality related problem solving and root cause analysis during design and manufacturing. Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required. Performs independent technical assessment on product quality performance and post market product quality analysis. Provide leadership and oversight to ensure Quality Management System Compliance. Be able to plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement systems. Ensure the compliance requirements are met during Design review , design verification & Design validation , Design transfer. Apply and facilitate Design for Quality & Reliability best practices (FMEAs, robust design, V&V, root cause analysis & problem solving). Youre the right fit if: (4 x bullets max) An Engineering degree in any discipline with at least 8+ years of relevant industry experience. Core expertise in Design Quality, Systems Engineering, or Reliability Engineering. Medical device industry experience is mandatory . Ability to define detailed systems quality and reliability plans for new medical product developments to ensure those are safe, effective and reliable. Ability to contribute to Risk Management and lead FMEA activities for new products and assurance that control measures are translated in appropriate critical requirements. Strong exposure to application of Design Controls; ability to do thorough Design Reviews during new product development to ensure robust designs that further improve patient safety and product quality. Ability to partner with V&V teams to assure thorough Verification, Validation and Usability testing. Ability to lead reliability analysis to assess the risks associated with design concepts. Experience with adequate and accurate review of DHF and DMR documents. Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, , and ISO 14971. Experience with working in multidisciplinary teams in a high-tech R&D environment. You continuously strive for excellence as a way of life and can inspire others to adopt this mentality of prioritizing quality above all else. You are a self-starter who embraces the change How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company s facilities. Field roles are most effectively done outside of the company s main facilities, generally at the customers or suppliers locations. Indicate if this role is an office/field/onsite role.

Quality Engineer (Industrial Flooring) - Avcon Technics Private Limited We are seeking an experienced Quality Engineer with 4 years of experience in the industrial flooring industry . The ideal candidate should have a strong understanding of concrete technology, flooring systems, and quality control processes to ensure high standards in our projects JOB DESCRIPTION Job Title : Quality Engineer (Industrial Flooring) Experience Required : 4 Years LOCATION : Jamnagar Key Responsibilities: Implement and monitor quality control procedures for industrial flooring projects. Signing quality report before concrete casting. Conduct quality audit weekly basis. Highlight the quality deviation. Understanding of concrete mix design & changes for suitability as per site condition. Modification in quality systems if required updation. Submit quality report to the management Highlight the quality discrepancies & challenges in maintaining the quality. Conduct inspections and tests on concrete materials, surface preparation, coatings, and flooring systems . Ensure compliance with industry standards, client specifications, and company quality policies . Investigate and resolve quality-related issues , including root cause analysis and corrective actions. Maintain quality documentation such as test reports, inspection records, and compliance certificates . Collaborate with project teams to optimize flooring application techniques and improve overall quality. Conduct training sessions for site teams on quality standards and best practices . Liaise with vendors, suppliers, and clients to ensure material quality and adherence to specifications. Stay updated on new technologies and advancements in industrial flooring and concrete. Key Skills & Qualifications: Bachelor s degree/Diploma in Civil Engineering, Materials Science, or related field . 4 years of experience in quality assurance/control in industrial flooring or related fields. Strong knowledge of concrete mix design, curing methods, and testing procedures . Familiarity with industrial flooring materials such as epoxy, polyurethane, and polished concrete . Hands-on experience with NDT (Non-Destructive Testing), surface profiling, and adhesion testing . Understanding of ISO, ASTM, BIS, and other relevant quality standards . Proficiency in quality management systems (QMS) and reporting tools. Excellent analytical, problem-solving, and communication skills. Preferred Qualifications: Certification in Quality Management (ISO 9001, Six Sigma, etc.) . Experience in working with large-scale flooring projects . If you are a dedicated Quality Engineer with expertise in concrete and industrial flooring , we encourage you to apply and be part of our team!

Grade G - Office/ CoreResponsible for managing a team accountable for delivering Property Management support to a number of sites including lease administration, ensuring compliance and renewal requirements are met, property management databases are accurately maintained and assisting in the design and delivery of new process initiatives. Entity: People, Culture & Communications Business Support Group Job Description: The Workplace Services for India manages all services across offices in India, c.41,000sqm, with potential to increase to c.150,000sqm. Our goal is to operate these offices safely, sustainably, and commercially while staying within business budgets. These services are crucial to ensuring that our business entities and enabling functions can operate efficiently and safely. Additionally, we provide a secure environment for employees within the office. The role also requires strategic inputs into the three-five property planning cycle to meet the evolving needs of the business. Key Responsibilities: Workplace Operations: Accountable for the strategic operation and governance across the India region. Expat Services: Accountable for the strategic support to expats across India in collaboration with International Mobility Strategic Property Planning: Collaborate with workplace SMEs to build a three-five-year strategic outlook and planning cycle, aligning property space requirements with the strategic needs of the business. Safety and Compliance: Ensure safe, reliable spaces and operations, adhering to robust safety protocols and compliance standards in line with BP s practices. Financial Management: Manage the country s financial performance against a budget responsibility of c.$8.5m, ensuring efficient financial oversight and cost control. Operational Excellence: Oversee the strategic management of office services across India to ensure they are consistently driven in a balanced, efficient, and effective manner. Change and Growth Programs: Drive strategic change and innovation in alignment with business needs. Third-Party Supplier Management: Across India, ensure third-party suppliers meet performance standards aligned with BP s global policies and follow local legislation, capturing and acting on any regulatory changes. Governance and Risk Management: Meet governance requirements with comprehensive documentation and management policies to mitigate workplace risks. Business Relationship Management: Foster positive relationships with all BP entities, ensuring services meet both current and future business needs in collaboration with workplace SMEs. Act as the primary escalation point at country level for regional businesses, ensuring regular communication with business leaders on all workplace activities and providing timely, accurate information and data to support strategic decision-making. Team Performance Management: Lead and manage a team of 3 direct reports, conducting annual goal settings, monthly performance reviews, and one-on-one meetings to ensure performance and development. You will work closely with both permanent and outsourced operations teams across India. This includes direct collaboration with country heads, PC&C leads, and regional SVPs. Adaptability is key as you engage with a diverse range of cultures and languages. You will collaborate with workplace SMEs to align office services with the business s strategic goals. An important aspect of this role is to become trained to the foundation level in the Vested methodology. You will also be responsible for ensuring that new team members receive adequate training in this methodology. You will be accountable for Managing operating and project costs of c.$4m associated with the office portfolio in India Delivering office health safety and risk to bp standards Supplier performance management at all India offices for third party services across multiple services lines Delivering agreed core building and office services directly or through vendor partners, maintaining the highest operational quality levels Managing key collaborator relationships and understanding the needs of their business Collaborate with Technology, PC&C and Workplace SMEs to ensure that all colleague services requirements are continually met. Actively Promote Vested methodologies Crucial Experience and Job Requirements: A minimum of 10 years experience in the workplace industry Well-developed interpersonal communication style and demonstrable inclusive leadership skills Experience in achieving results in diverse cultures drives an inquisitive yet respectful attitude whilst promoting innovation and continuous improvement Knowledge of managing process efficiency, data quality, systems performance and development, project & programme management and change control, with respect to implementing attitudeworkplace services outsourcing initiatives Entrepreneurial thinking, demonstrating extensive understanding of business inter-connectivity and the ability to act upon this understanding A successful track record of initiating, leading and managing multiple service functions in a sophisticated environment whilst simultaneously transforming the services Leading and encouraging internal and outsourced partnerships and teams to deliver high levels of achievement and innovations sophisticated Experience of leadership within property and workplace services in a large multinational organization Previous experience of facilities & property management, preferably in a global enterprise with a diverse range of operations, property types and installations Proven experience of managing FM service contracts and in managing multi $m Outstanding stakeholder engagement skills, building sustainable networks of high Emotional Intelligence Confident individual who takes ownership and leads by example Desirable criteria: Having previously worked with the Vested methodology Excellent communication skills both verbal and written, collaborative and flexible style Experience and knowledge of using health and safety, environmental and quality management systems Significant experience gained whilst working in an operational environment with a focus and culture of critical environments and HSSE Appropriate language skills to operate in geographical context We are an equal opportunity employer and value diversity at our company! We do not discriminate based on race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Travel Requirement Negligible travel should be expected with this role Relocation Assistance: This role is eligible for relocation within country Remote Type: This position is a hybrid of office/remote working Skills: Building services and standards, Building sustainability, Communication, Continuous improvement, Contract Management, Curiosity, Customer centric thinking, Diversity, equity and inclusion, Financial Analysis, Integrated Planning, Long Term Planning, Project execution planning, Real estate and location Strategy, Safety Leadership, Strategy and business case, Supplier Relationship Management, Translating strategy into plans, Waterfall Model, Workplace colleague experience

India Quality Manager India HOW MIGHT YOU DEFY IMAGINATION Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has also invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring an India Quality Manager in India . Live What you will do Reporting to the Senior Manager International Quality JAPAC, the responsibilities of your role will cover, but are not limited to the following: Main Responsibilities Implement Amgen Quality Management System Identify Continuous Improvement opportunity for Quality Management System Develop Quality Procedures align with Amgen Quality Management System, cGMP requirements, GDP requirements and local regulations Oversight operations of local distributors and stockist to ensure local distributors operations are in compliance with cGMP requirements, GDP requirements, Amgen Quality Management System and Local regulations Act as Quality-related interface with internal and external customers (i.e. Change control, Non Conformance, Product Complaint, Product Recall, Audit/ Inspection) Support local testing Support BD project and product launches Liaise with internal and external partners to manage day to day operations associated with distribution operations Monitor and ensure on time completion of NC, CAPA, Audit observation, Product complaint and other quality events Develop and Maintain the Quality Agreements with local distributors and partners Develop reports and provide the necessary communications throughout the organizations Develop or review or approve GMP and GDP documents Provide training to distributors and stockiest including distributors/stockist on-boarding training Actively participate on GMP intelligence to review local regulations, standards and guidance related to Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), product testing and Pharmacopoeia requirementsin India. Collaborate with Risk Management and Product Security on handling of counterfeit, product tempering, product theft and product diversion Interact with local regulators as needed. Keep the Senior Manager International Quality – JAPAC informed of the progress of projects and goals and advise on the potential areas of risk/ concern and new developments that may impact the company Support Named Patient Program Supplier ManagementPerform quality oversight and audit of key suppliers to Amgen and its subsidiary companies. These suppliers can include API and starting material manufacturers as well as raw materials, devices and finished products suppliers , contract facilities, local laboratories, importers, distributors, logistics service providers, warehouse, etc. Apply advanced knowledge of Indian and global market regulations to assess supply security risks. Work on an active risk management tool etc. to appropriately deploy Quality Systems on oversight of Amgen suppliers; including selection and approval, due diligence assessment, intelligence monitoring, on-site visit/audit and (if needed) Person in Plant placement, etc.. Support in identifying, assessing and addressing supplier’s GMP/GDP risks in collaboration with Amgen sites. Execute necessary tasks and projects as assigned by management in timely manner; to attain assigned goals. Provide support for regulatory inspections of key facilities as needed. Win What we expect of you Qualifications Pharmacist Registration in India. Hold a valid practicing certificate as Pharmacist in India. In-depth knowledge and experience of Good Manufacturing Practice (GMP) & Good Distribution Practice (GDP). Experience with Quality Management Systems including but not limited to change control, deviation, validation, complaints, disposition and audits/inspections. Experience with Commercial Quality Operations and third-party management. Experience with distribution models and/or establishment of new entity procedures a plus Thrive What you can expect of us As we work to develop treatments that take care of others, we work to care for our teammates’ professional and personal growth and well-being. Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Job Category: Research & Development Job Family: Research and Development Job Description: To develop new products based on projects assigned by the Team leader of Product Development, Sales or internal customer to be delivered on-time, on-budget, and on-target, What You'll Do Responsible for project management and good stakeholder management, product development principles, basic food regulatory understanding, R&D processes, protocols Has good verbal/ written communication skills dealing with people from product development backgrounds Develops & creates prototypes, carry out sensory, analytical evaluation and benchmarking of market products Guides product development in product approval at customers end Leads and works directly with production and QA team to ensure trial runs and start-up operations are properly performed for all new product development and improvement projects Development of efficient process from R&D lab scale trials to plant scale by understanding the process in detail and upscaling on production floor Work closely with cross functional team and help to fulfill the needs of R&D projects Should be ok for travel for product trials and product evaluation Able to work at flexible working hours when needed, Supervises product development technicians to maintain accurate inventory of R&D supplies, ingredients and finished good samples Maintain a tracking sheet for all these inventories Develops standards and audits the product development assets for 5S readiness, Ability to develop analytical methods on new and existing ingredients and products, Leads shelf life reports on ingredients and products, Maintaining complete NPD documentation, Operates, performs needed preventative maintenance, and maintains various pilot plant equipment utilized to manufacture pilot bench top samples Completes clean-in-place (CIP) and related sanitation tasks for the pilot plant unit & lab Responsible for ensuring work area is clean and organized, Develops systems & procedures to ensure Safety and standardized work Committed in ensuring food safety in product and process Responsible for establishing HACCP plan for new products, Responsible for all other duties as assigned by Team Leader Product Development, What You Need To Succeed Bachelor's degree/ Master's Degree in Dairy Technology/ Dairy Chemistry, 3-6 years' experience in research and/or product development, Incumbent should be sound in Natural & Processed Cheese manufacturing technology, awareness of formulation design, process improvement & modification, Well versed with the Food safety principles, HACCP and quality systems Cultured dairy products manufacturing experience preferred, Strong analytical and dairy component understanding, Desire to grow and take on new challenges and opportunities, Ability to travel up to 10%

We are looking for a detail-oriented and proactive Manufacturing Executive to support and optimize our production operations. The ideal candidate will be responsible for analyzing production data, ensuring labour and equipment availability, and maintaining efficient production workflows Job Responsibilities: Provide manufacturing decision-making information by calculating production, labour availability, reviewing production schedules. Develops manufacturing processes considering the best utilization of inhouse capabilities meeting product specification. Improves manufacturing efficiency by analysing and planning workflow, space requirements, equipment layout and process automation. Collate, analyse, and tabulate data to drive correlations and interpretations for improvement. Organising and repairing and routine maintenance of production equipment. Maintain the Production Control & Planning system in line with daily production requirements. Ensuring adherence to Quality systems, maintaining documents to ensure complete in process quality and improvement in process capabilities. Conducting internal audits and risk assessment. Develop and Ensure adherence to the SOP (manufacturing process) during production. Maintain a safe, clean work environment. Skills: Willingness to lead, take charge, and offer opinions and direction. Job requires being careful about details and thorough in completing tasks. Job requires Adaptability to changes driven by culture. Willingness to upgrade knowledge and traits, Aspiration to develop talent. Taking ownership of our work, doing what is needed without being asked. Planning ahead, managing time we'll, being on time, being cost conscious, thinking better ways to do things. Requirements: Diploma or BE/B Tech in Mechanical/Industrial engineering, Food Technology with 2-4 years experience with specific knowledge on Food Safety Management Systems, HACCP & Lean manufacturing. Experience in Sweets and horizontal form fill seal operations experience will be an added advantage. Proficient in Computer skills in MS Office and analytical applications Experience in effective usage of data analysis, tools, and statistical analysis

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Pall Corporation, one of Danaher s 15+ operating companies, our work saves lives and we re all united by a shared commitment to innovate for tangible impact. You ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher s system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers solve their toughest challenges. Our products serve diverse, global customer needs across a wide range of applications to advance health, safety and environmentally responsible technologies. From airplane engines to hydraulic systems, scotch to smartphones, OLED screens to paper everyday Pall is there, helping protect critical operating assets, improve product quality, minimize emissions and waste, and safeguard health. For the exponentially curious, Pall is a place where you can thrive and amplify your impact on the world. Find what drives you on a team with a more than 75-year history of discovery, determination, and innovation. Learn about the Danaher Business System which makes everything possible. Working to support Pall strategic and operational business objectives, The Manager, Digital Operations exists to execute the manufacturing technology strategy. The Manager, Digital Operations will work directly with business unit operational executives and managers to convert business objectives into actionable technology plans and projects. The Manager, Digital Operations will also have responsibility to ensure the company s information and processes are functioning appropriately to support business operations. In addition, the manager will work with IT to promote leveraging of all assets and processes to support Pall. Our IT organization is transforming how we work at Pall. We collaborate with our business partners to deliver a best in class, valued added and cloud-based solutions, modern user experience with an engaged global team and secure enterprise. This position is based in Pune, India. In this role, you will have the opportunity to: Consult closely and develop a working relationship with manufacturing and supply chain management leads to support business plans and objectives through the identification, evaluation, and prioritization of opportunities to leverage Pall s IT investment. The position will also work with the various business unit operations leaders to improve processes through improved utilization of information management. Establish and oversee the various project development and support functions and ensure effective and efficient procedures and programs according to the IT policies and strategies. Lead Digital Manufacturing Technology teams to solve manufacturing facilities toughest problems, providing end-to-end support to ensure value is delivered and sustainable. Partner with key stakeholders to co-develop strategic functional roadmaps and oversee the associated project portfolio. Provide technical vision and leadership to ensure that current and new manufacturing processes are robust, efficient, and meet current quality and regulatory expectations. Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve; establish an effective technical and leadership development plan for the Digital Operations IT organization. Plan and manage strategic reductions and optimizations of process complexity through standardization of underlying technology across business platforms and business units. The essential requirements of the job include: Bachelor s degree in a quantitative or analytical field. Expert knowledge with at least 10 years experience in project management and implementation of large-scale business projects. 5 or more years of experience with Enterprise-class manufacturing applications preferably DMC or SAP MES. Experience with integrating manufacturing technology to ERP platforms is preferred. Demonstrated ability to lead teams across the digital operations ecosystem and make decisions based on key business priorities. Substantial knowledge of business functions, processes and supporting technology in an industrial company. Specific business experience in operational and manufacturing technology platforms required. Experienced in information and data management for manufacturing and operations process improvement. Knowledge and experience in implementing and integrating various automation and robotic technologies, ie AGVs; knowledge of various PLC and process control technologies; and implementing quality systems. Up to 20% travel including international. Join our winning team today. Together, we ll accelerate the real-life impact of tomorrow s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The Sr. Manager FS - IN PB serves as a pivotal leadership position within Amazon Indias Operations compliance organization, spearheading food safety and quality initiatives for the Consumable Private Brand (CPB) portfolio. This role drives strategic compliance decisions that directly impact business growth, customer trust, and regulatory adherence across a complex network of manufacturing facilities, some managed through strategic sellers. The role will oversee end to end process from pre-launch (e.g., supplier/ vendor development, supplier/ vendor onboarding audits, technical product specification finalization, artwork clearance, licensing management, transit/ drop tests, etc.) to post launch (e.g., monitoring process and end product specifications and compliance, shelf life monitoring, customer/ regulatory contact management, recall, etc.). With oversight of a strong gross margin sales portfolio comprising diverse food products across multiple categories, this position demands a unique blend of technical expertise, strategic thinking, and influential leadership to navigate evolving regulatory landscapes while maintaining Amazons high standards for product quality and safety. The role serves as the primary authority for food safety compliance, interfacing regularly with senior leadership while building robust quality management systems that protect both customer experience and business interests. In next 1-2 years, the role will be responsible for creating/ setting up scalable and robust compliance and quality improvement mechanisms and solutions which support Amazon s consumables private brands complaint expansion and delightful customer experience. The role will create strategic and tactical planning for the India Private Brands Charter and will effectively write business review documents, collaborating and influencing Private Brands, Product, Technology, Legal, Supply Chain partners. Your success will be measured not just in compliance metrics, but in your ability to build sustainable systems that support Amazons continued growth while maintaining our commitment to product quality and safety. This role will report to the Head of Food Safety - India. You will lead Amazon Indias Private Brand food safety initiatives. You will develop/ execute or exercise oversight on food safety management strategies that protect customers and business interests. This includes food safety/ legal/ statutory policy definition, update, efficacy check oversights for ensuring food safety across suppliers/ vendors, processing and packaging. You will ensure Amazons food safety programs meet current and future regulatory requirements. You will manage quality improvement and compliance adherence programs for the consumables Private Brands business across 50+ vendors/ suppliers. Key focus areas include: leveraging customer feedback and regulatory contacts to identify actionable insights to improve product Quality. You will oversee supplier onboarding (identification and creation as well), licensing requirements, product trials/ launch, process specification/ product technical specifications finalization, artwork clearance and subsequent labelling compliance, specification testing programs, internal audits (PRPs/ standards as applicable basis category), sensory testing and shelf life management, process specification inspection, product quality inspection, product clearance, post-dispatch management- recalls, withdrawals, customer and regulatory contacts, internal (regional/ supplier or vendor wise)/ external (market) benchmarking. Your role ensures quality systems scale with business growth. Your responsibility includes identifying applicable standards (ISO/ GFSI/ FSSAI Schedule IV), conducting on-site second party audits, providing direct/ indirect guidance to category/ business and suppliers/ vendors, and driving improvements in manufacturing practices. You will standardize quality requirements and lead supplier/ vendor assurance programs. You will stay updated on dynamic and evolving regulatory landscape in India to proactively interpret, communicate, and establish/ modify policies in close collaboration with legal, categories/ business. This includes managing requirements across all product categories, including new segments like pet food, nutraceutical. You will build frameworks to identify and address risks, ensuring product safety and regulatory compliance for Amazons consumable private brands. You will connect quality and compliance requirements with business objectives, working with stakeholders across functions - Business/ Category, Legal, Product, and Technology. This includes regular engagement with senior leadership on quality and regulatory matters. You will guide decisions affecting operations and strategy, requiring both technical expertise and strong communication skills, owning/ leveraging strategic and tactical plan document writing. You will support business expansion while maintaining quality and compliance adherence standards. This includes supporting selection expansion requirements requiring onboarding both new sellers/ suppliers/ vendors and new products - SKUs/ Food Category. You will implement quality monitoring and control solutions, including automated systems for data collection and analysis. This includes developing quality metrics, creating reporting systems, and analyzing customer/ regulatory feedback, using data to identify trends and guide quality initiatives. Your focus will be on developing efficient, scalable quality management processes that efficiently adapt to or scale with business growth.

BACKGROUND The Hans Foundation, established in 2009, is a Public Charitable Trust that that works for the improvement of quality of life for underprivileged communities across India through Health, Education, Livelihood and Disability sector interventions. THF undertakes direct implementation of projects on the ground in addition to providing funding support to not-for-profit organisations in India through its donor - RIST, USA. THF s Strategic planning focuses on key areas of its work with the aim of addressing the key issues of poverty alleviation, economic inequalities, and 360 impact on the quality of life through social development programs. THF s programs are majorly implemented in the most rural and under-developed areas in the country. Over the years, THF has expanded its charitable activities in collaboration with State and Central Governments, institutions, corporates, academia and non-government organizations for sustainable interventions to achieve scale and economy. The interventions implemented by the foundation range from grass root level to national level programs. PROJECT OVERVIEW: ITC CSR MMUs - Assam The Hans Foundation, in collaboration with ITC Limited has launched an innovative Mobile Medical Unit (MMU) project in the Kamrup District of Assam. This initiative is designed to extend much-needed healthcare services to underserved communities, tackling significant health issues that have been identified through comprehensive secondary research as well as our extensive hands-on experience in the region. The primary aim of the Mobile Medical Units (MMUs) is to dramatically improve healthcare access for the underserved rural populations residing in Rampur, Chaygaon, Bongaon, and Chayani Bardur within Kamrup District. These mobile units will deliver a wide array of essential medical services, focusing on preventative care and health education while directly addressing the prevalent health challenges faced by these communities. As a result of the MMU program, we anticipate fostering a healthier, more resilient population in Kamrup District. By bridging the gap in healthcare access and increasing health literacy, the MMUs are poised to engage with the community actively. This initiative will not only address immediate health concerns but also contribute to the long-term well-being and vitality of residents, empowering them to lead healthier lives and strengthening the overall fabric of the community. GENERAL Location of Job: Boko, Assam Annual Salary : Salary will commensurate with education, experience of the candidate and past salary drawn. No. of position: 3 1. JOB PURPOSE The Medical Officer will be responsible for medical check-ups of the serving community through Camp duties at MMU following the visit roster, treating and providing consultation to the patients and maintaining. The Medical Officer will analyze medical check-up data and conduct regular inspection of equipments, maintaining the inventory of medicine required at MMU. S/he ensure compliance of the requirements and protocols as per Govt Rules. S/he will present the data to management and make suitable action plan. 2. KEY ACCOUNTABILITIES Conduct MMU camp duties as per visit roster and perform medical check-ups of the serving community. Supervise and ensures the availability of inventory and supplies of drugs, reagents and equipment as required at MMU. Conduct home visits for elderly/ severely sick patients and persons with disabilities. Collaborate with other specialists and health facilities for timely, right referral of required cases. Analyse medical check-up data of the patients and provide counselling sessions as required. Management of the team and their capacity building. Ensuring optimum utilisation of available resources of the MMU. Maintain the confidentiality of the patient data and adhere the IPHS/IMC protocols for the treatment. Adhere and ensure implementation & enforcement of Protocol/Quality systems. Ensure that documents like OPD, medicines and reagents consumption, patients cards etc. are updated and maintained regularly. Inspect the requisition and viability of medical equipment & instrument at the MMU. Create awareness on health topics by participating in campaigns organized through MMU. Share the success stories/anecdotes from the field. Prepare trends of communicable and non-communicable diseases. Attend the periodic review meeting organized by THF team. Any other duties that may be assigned from time to time by the THF management. 3. Reporting to : Project Manager/ Project Coordinator 4. Other Indicative Requirements Educational Qualifications: MBBS Functional / Technical Skills and Relevant Experience & Other requirements (Behavioural, Language, Certifications etc.) Minimum of 0-3 years of experience in public health programs with good team management skills. Candidate must have good communication skills in Hindi. Should be registered with Punjab Medical Council.

Brief team/department description: Our Digital team at Azurity is building new capabilities utilizing cutting-edge Lead IT Systems (R, Q & RIMS) Expert. We are looking for a dynamic, change inspired, Dwell b/w multiple system, Individual self-driven hands-on Lead IT Systems (R, Q & RIMS) Expert. Team Member Ability to work onsite during flexible hours to support India, US and EU operations Job Summary: We are seeking a dynamic and versatile Lead IT Systems with strong hands-on experience in Research, Quality Management Systems (QMS) and Document Management Systems (DMS), coupled with a working knowledge of RIMS and Lab Systems. This role requires the ability to wear multiple hats, supporting a cross-functional pharma IT landscape that spans Quality, Regulatory, and Laboratory systems. The ideal candidate thrives in a regulated environment, collaborates across functions, and ensures systems remain compliant, validated, and business aligned. Mandatory Qualifications: B.Tech / B.E. in Computer Engineering (Mandatory) M.Tech in Computer Engineering / IT (Preferred) Experience Required: 8-10+ years in IT within the pharmaceutical industry Deep hands-on experience with TrackWise, Veeva Vault QMS/DMS, AmpleLogic QMS, and exposure to RIMS and Lab Systems Expertise in CSV, GxP compliance, 21 CFR Part 11, and audit preparedness Strong involvement in data migration activities and end-user training Soft Skills (Mandatory): Strong verbal and written communication Effective cross-functional collaboration (Quality, Regulatory, Lab, IT) Growth mindset with ability to handle evolving platforms Product roadmap alignment and stakeholder influence Ability to navigate complexity and ambiguity in stakeholder conversations Multiple Hats" mindset - flexibility to contribute across QMS, DMS, RIMS, and Lab Systems as needed Ability to confidently demonstrate system functionalities and conduct user workshops Role Distribution: System Domain Focus Role Expectation QMS / DMS 70% Lead ownership of workflows, validation, support, and vendor management (Veeva Vault, TrackWise, AmpleLogic), Other evolving System RIMS 20% Support submission tracking, registration workflows, and regulatory readiness Lab Systems 10% Basic support for LIMS, MPower, instrument data integrity Responsibilities: Quality Systems (70%) -Core Hands-On Ownership Configure and manage QMS/DMS platforms (TrackWise, Veeva Vault QMS/DMS, AmpleLogic), Other evolving Systems Design and optimize CAPA, Change Control, Audit, Deviation, and Document Lifecycle workflows Execute and manage CSV lifecycle - URS, IQ/OQ/PQ, RTM Provide L2/L3 support, user training, SOP documentation, and handle audit readiness Coordinate directly with vendors for system updates, patching, and roadmap discussions Lead and execute data migration activities with validation and reconciliation Demonstrate QMS/DMS systems confidently to users and auditors Regulatory Systems (20%) - Supportive Ownership Administer Veeva Vault RIM or equivalent RIMS platforms Manage registration tracking, submission workflows, and HA interactions Collaborate with RA teams to gather requirements, support compliance, and maintain inspection readiness Lab Systems (10%) - Tactical Support Support AmpleLogic LIMS and MPower QC systems Monitor instrument integration and data flow (HPLC, GC, FTIR) Address sample tracking issues and logbook automation enhancements Technical Skill Set: Platform Expertise Level Hands-On Scope TrackWise QMS Expert CAPA, Deviation, Audit, Change Control Veeva Vault (QMS/DMS/RIM) Expert CAPA, Deviation, Audit, Change Control Controlled docs, QMS workflows, RIMS lifecycle AmpleLogic QMS/LIMS Expert Stability, sample tracking, electronic forms MPower (QC Systems) Proficient Batch/lab workflows CSV / Validation Expert GAMP 5, ALCOA+, 21 CFR Part 11 RIMS (e.g., Veeva RIM) Proficient Submission lifecycle tracking Data Migration Proficient Legacy to new platform migration, reconciliation Training & Demos Proficient Conducting user workshops, confident system walkthroughs Audit Readiness Expert System readiness, evidence generation Service Tools Proficient JIRA, ServiceNow Instrument Integration Intermediate Empower, Agilent, OpenLab Team Member is expected to wear multiple hats flexibly contributing to QMS/DMS ownership, RIMS support, and Lab systems troubleshooting as business needs evolve. Agility, accountability, and collaboration are key to success in this hybrid role. By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.

Key Roles Responsibilities: 1. Oversee and support the overall activities during the product development life cycle from quality perspective in RD (API and intermediates). 2. To understand the site needs with respect to system establishment and sustainability. 3. Author/ Review and approve the SOPs/work directions required for implementing the Quality systems in RD activities as per GLP and regulatory requirements. Ensure effective implementation of SOPs/ work directions. 4. Review and approve Lab Familiarization Reports (LFR), Product development reports (PDR), Technology transfer, product specifications STPs, analytical method validation, method transfer, qualification, calibration, process validation protocol and reports. Ensure effective execution of these activities. 5. Periodic audits of RD laboratory. Ensure online documentation and review lab notebooks, PDR/LFR documents, analytical documents and stability data. 6. Effective maintenance of RD records, distribution and archival systems. 7. Perform cGMP audit of RD facilities and operations. Assist the team in auditing contract manufacturers/ vendors/ contract testing laboratory. 8. Ensure RD team is trained for their relevant job function and GMP/ GLP training. 9. Provide quality related inputs to new projects, existing project, up gradations etc. 10. Participate in identification of key starting material (KSM)/ registered starting material (RSM) and ensure that it is correctly identified. 11. Participate in handling of OOS, OOT, Deviations, Batch failures, investigations and CAPA implementation at site. 12. Establish raw material standards by studying manufacturing/ RD requirements-conferring with suppliers. 13. Responsible to follow the safety and environmental procedures deployed in the site. Graduation and above in Science / Pharmacy

In-depth working knowledge of Quality systems in FMCG industry Hands on knowledge of Quality lab testing on chemical, physical, visual and functional parameters of the product. Hands on knowledge on equipment calibration & certification requirements Knowledge of ISO 9001:2015 [Certified lead/internal auditor] & experience of handling management representative (MR) role of a production unit Experience on design & implementation of new systems and process in the areas of quality. In depth knowledge of QC tools like Spec sheet, SPC charts, pareto, why-why analysis, histogram Certified in Six Sigma- Yellow/Green/Black belt Knowledge on Root Cause Analysis & complaints management system (CAPA) Knowledge on infestation control Experience on leading large-scale projects in the areas of quality Experience of driving quality ownership at production shopfloor through people initiatives. Proficiency in Office tools Excel, Word & Powerpoint Working knowledge of business analysis tools like- Power BI, Minitab etc

locationsHosur, Tamil Naduposted onPosted 14 Days Ago job requisition idR0000302475 Career Area: Manufacturing About The Role : Your Work Shapes the World at Caterpillar Inc. When you join Caterpillar, you'rejoining a global team who cares not just about the work we do but also about each other. We are the makers, problem solvers, and future world builders who are creating stronger, more sustainable communities. We don'tjust talk about progress and innovation here we make it happen, with our customers, where we work and live. Together, we are building a better world, so we can all enjoy living in it. Primary responsibility is to provide support for Quality initiatives in Supplier Quality & Facility Operations. The Position will ensure conformity to global quality processes defined in the Caterpillar Quality Management System (QMS). Provides conclusions and recommendations for quality issues and/or continuous quality improvement projects. Participates in supplier quality improvement initiatives; works with Suppliers to develop and improve quality levels. Ensures the reliability and quality of suppliers, implementing process controls, certification programs, evaluations, inspections, corrective actions, audits and records. Identified quality problem(s) and determines a short-term action plan with the facility management and the supplier JOB Duties: >The incumbent will assure, supplier parts meets the Caterpillar specifications and provide the guidance to Suppliers with following job roles, * Identify root causes for the Non-Conformance and communicate to respective Suppliers to initiate ICA / PCA. * Ensure effective containment actions are initiated along with Supplier for CIPL stock parts / material in transit. * Ensure Suppliers are implementing ICA / PCA before shipment & communicate the same to internal stake holders. * Ensure all BIQ issues are addressed & effective actions are implemented. * Co-ordinate with respective Suppliers for robust PCA and support in achieving PPM & DPU as per facility targets. * Monitor Supplier performance & initiate actions to improve with respect to Quality. * Initiate quality review meetings & review actions on periodic basis with Suppliers. * Take lead in CQMS certification & ensure all requirements are met. >The incumbent in this position is responsible for overseeing the execution of processes, plans and tools that support global quality systems or related processes i.e. Cost of Poor Quality, APQP, PPAP, Quality certifications, etc. The incumbent must also ensure alignment to CPS (Caterpillar Production System) principles. Develop, implement, monitor, and execute quality plans for Supplier parts and assess capability and stability to make sure Parts flow through green channel to production. BACKGROUND/EXPERIENCE 1. Bachelors degree in mechanical engineering with an excellent understanding of Quality management practices. 2. Mandatory minimum 5 years of work experience as Supplier Quality Engineer. 3. Strong Technical knowledge of Machining process of precision Steel & Cast-Iron parts 4. Understanding & analysis of CMM inspection reports 5. Requires strong communication, cooperation, and influence skills to work with all levels of employees and customers. 6. Requires quality tools knowledge and to be able to teach other on how to properly apply quality tools or techniques 7. Advanced computer applications, good oral and written communications skills are a must Posting Dates: April 30, 2025 - May 14, 2025 Caterpillar is an Equal Opportunity Employer (EEO). Not ready to apply? Join our .

Exp Textile Industry Supervise & control the Testing in Lab to analyze specifications of materials as per Customer standards.Coordinate with Stores about Raw Materil & Import RM sampling.Ensuring testing of Raw Matrial, In-proces & per Required Candidate profile Testing of all incoming chemicals & chips & in process testing. Approve or reject materials based on the test results.Highlighting the property deviation.Ensuring re-test in case of abnormal test res

Hope International Hospital is looking for Nursing Superintendent to join our dynamic team and embark on a rewarding career journey Manage the nursing department and oversee the nursing staff Develop policies and procedures for the nursing department to ensure the highest level of patient care Provide training and education to nursing staff to ensure they have the necessary skills and knowledge to provide quality care Collaborate with other healthcare professionals, such as physicians and therapists, to develop and implement patient care plans Maintain accurate records of patient care and nursing department activities

Essential Qualification: B.E./B.Tech in Mechanical, Civil, or Chemical Engineering Minimum 18 years of total experience, with at least 12 years in Quality Assurance/Quality Control, specifically in large-scale industrial desalination, water treatment, or Water infrastructure EPC projects. Must hold Lead Auditor Certification in ISO 9001:2015 Desirable Qualifications: ASNT Level II / Level III in Non-Destructive Testing (NDT) CSWIP / AWS-CWI Welding Inspector Certification Certification in Water Quality Management, Desalination Technology, or Reverse Osmosis Processes Additional Qualifications: Six Sigma Certification Certified in 5S, Kaizen, EFQM, or equivalent Quality Excellence Programs Job Description: Develop, implement, and continuously improve a comprehensive QMS aligned with ISO 9001:2015 Prepare and approve quality documentation such as Project Quality Plan, Inspection and Test Plans, Method Statements, Material submittal logs, in alignment with client specifications, international codes, and industry best practices. Provide strategic oversight to QA/QC teams across multiple projects, ensuring timely inspections, audits, compliance, and close-out of Non-Conformances (NCRs). Interface with internal customers engineering, procurement, and construction teams to integrate quality requirements early in the project lifecycle. Establish and maintain vendor and subcontractor quality control systems for fabrication, assembly, and erection of water treatment equipment, pipelines, mechanical systems, and civil structural elements. Lead regular Quality Review Meetings with clients, contractors, and third-party inspection agencies to monitor KPIs, resolve quality issues, and ensure proactive control. Review and approve test reports, calibration records, and material traceability documentation for desalination components (RO membranes, pumps, pressure vessels, etc.). Conduct Internal & External Quality Audits and provide strategic recommendations to align with evolving regulatory and compliance requirements. Ensure project-wide quality training, toolbox talks, and motivational programs for all levels of staff to maintain a quality-focused culture. Maintain accurate records of inspection reports, audits, and quality documentation to support project handover and warranty phases. Serve as a technical mentor to QA/QC Engineers and Inspectors, ensuring competency development and alignment with project goals. Act as a client-facing authority on all quality-related matters throughout the project lifecycle, from design review to commissioning. Key Competencies: Proven leadership track record in driving quality systems, compliance, and operational excellence across large EPC projects in water treatment and desalination infrastructure. Excellent documentation, communication, and team leadership skills Thorough knowledge of codes & standards

Customer complaints management , Customer satisfaction Reduce the cost of poor quality Support to new development project Implement cost saving projects Implement cost saving projects Implement QMS Training and awareness Required Candidate profile knowledge of process improvement tools / techniques such as 6 sigma, VDA / Lean manufacturing team leading experience with Audit and Supplier quality

Develop and implementation of the Quality Management System Deep knowledge of IATF 16949:2016, ISO 14001:2015 & ISO 45001:2018 Co-ordinate with external auditors Audit findings and NC closure Hyundai 5Star audit follow up Knowledgeof APQP, PPAP ISIR

ISO Documentation,Quality Manual & Procedures, licenses & Regulatory Compliance, Internal Audits & Closure Reports,Design File Management,Maintain records of ECNRs

Key Responsibilities Having exposure of 1-4 years in analytical chemistry, method development and analysis of regular samples on chromatographic instruments (LC-MS). Candidate should be well acquainted with the respective instrument and software. Maintenance, cleaning, documentation and calibration of analytical instruments. Demonstrate perseverance, team co-ordination and analytical approach at the work place. Should be flexible with working hours. Provide training to new joiners. Practice safe work habits including complying with all safety health and environmental rules and regulations Person Profile Qualification: - M. Sc. (Analytical Chemistry)/ M. Pharm or related field from reputed university/institute. Experience: - 1-4 years of relevant experience for Masters.

PRODUCT QUALITY SPECIALIST What you will do Let’s do this. Let’s change the world. In this vital role you will provide technical expertise and product leadership to the Product Quality (PQ) organization. As a product support staff in Quality, the Product Quality Specialist has responsibility for working with Product Quality Leaders (PQL), International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other groups on projects including support of product specifications, in-process controls, periodic and annual product review, and complaint resolutions. Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies we’re employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients. This role will support one or more late-stage and/or commercial biologics or synthetics products. The individual will provide project support to the relevant Product Quality Team (PQT) to implement and manage strategy for Quality to meet the Product Quality goals. The individual will be directly responsible for Product Quality related tasks including authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (document management system, complaint resolution system, data systems), and product data management, including stability, comparability assessments, periodic and annual product reviews (APR). In addition, the candidate will be expected to play a role in supporting Product Quality initiatives intended to ensure the overall product health. Support PQ work for late-stage and/or commercial biologic or synthetic programs, including actions required for the PQT, APR, specifications, comparability, stability programs, and PQ owned regulatory filing sections and responses to questions (RTQ) Support science and risk-based evaluation of complex process and product quality data such as in-process, release and stability data, complaints, method performance etc. What we expect of you Basic Qualifications and Experience: Doctorate degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 2 years of Quality, Operations, Scientific, or Manufacturing experience, or Master’s degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 6 years of Quality, Operations, Scientific, or Manufacturing experience, or Bachelor’s degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 8 years of Quality, Operations, Scientific, or Manufacturing experience or Preferred Qualifications: Must-Have Skills: Demonstrate proficiency in oral and written communication of complex information to Product Quality team members and peers Demonstrate proficiency in knowledge of cGMP and international regulatory expectations Strong scientific data management and organization skills with attention to detail Ability to deliver high quality results and adhere to project timelines using computer-based GMP Quality systems Ability to build and maintain multi-functional relationships and strong partnerships through written and verbal communication skills Good-to-Have Skills: Experience working virtually on a multi-functional team in a matrix environment across multiple time zones Expertise in computer applications such as Veeva, Spotfire, SHINY Expertise in MS Office (Word, Excel, PowerPoint, MS Teams) Soft Skills: Analytical and problem-solving skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully, react quickly to address urgent requests and meet challenging timelines Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.