17 Regulatory Inspections Jobs

The Quality Lead position at ProPharma involves driving positive change and process improvement in the assigned region. This role serves as an independent and objective entity, supporting various operational teams and performing quality activities as per ProPharma Group's Quality Policy and procedures. The Quality Lead is responsible for Audit Management, Deviation and CAPA Management, Document Control, and other Quality Management System activities. Developing, managing, and executing quality management processes to ensure compliance with regulatory requirements is a key aspect of this role. Essential Functions: - Maintaining awareness of and ensuring adherence to applicable SOPs/controlled documents, regulations, guidelines, and client agreements. - Serving as a control point for SOPs/controlled documents and Quality Management System documents. - Contributing to the creation of controlled documents such as SOPs and Work Instructions. - Supporting the internal quality program including quality assurance and quality control. - Assisting in investigating service complaints and deviations, identifying root cause and CAPAs, and communicating these to the Managers. - Collaborating with Operational and Client Services Managers to support preparation for client audits and regulatory inspections. - Hosting client audits and regulatory inspections at ProPharma Group and acting as an SME for quality topics. - Developing responses to CAPAs arising from client audits and regulatory inspections, with support from Operations Managers, Client Services, and Global Quality, and tracking to completion and closure. - Participating in relevant client operational meetings as directed by Management. - Supporting the Quality Manager in the Regional Quality Committee and acting as a regional representative in the Global Quality Committee. - Proactively identifying improvement opportunities to support the development of ProPharma Group as a leading provider of outsourced global Medical Information solutions. - Identifying any issues that could potentially impact services and escalating areas of concern within the business to Management, with potential corrective actions. - Other responsibilities as assigned. Necessary Skills & Abilities: - Excellent attention to detail and focus on quality. - Strong verbal and written communication skills. - Excellent workload management skills. - Ability to prioritize workload and meet deadlines. - Excellent questioning and listening skills. - Capable of resolving conflict constructively. - Able to collaborate with colleagues in other departments effectively. - Ability to speak effectively in interpersonal situations and presentations. - Possesses a service-oriented approach. - Flexible and proactive toward changing needs. - Good understanding of quality assurance regulations and guidelines, preferably related to cGxP. - Quality Assurance experience in internal and external audits, maintaining regulated documents, and training files, preferably related to cGxP. - Knowledge of FDA regulations for adverse event and product complaint reporting. - Proficiency in MS Word, Excel, and PowerPoint. Educational Requirements: - University/Bachelor's degree and/or appropriate relevant work experience. Experience Required: - 5 years Quality experience in pharmaceutical or medical device industries or other regulated industry. - Previous experience in data mining, analysis, and presentation. - Previous audit experience preferred. ProPharma Group is committed to diversity, equity, and inclusion, creating a workplace where employees can be their authentic selves and are encouraged to be innovative and collaborative. As an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. Please note that ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Phone calls or emails regarding this posting are not accepted.,

The role holder will be responsible for handling Regulatory Compliance in respect of third-party products (insurance, mutual fund etc.) distribution business of the Bank. Handling Regulatory Compliance for the Bank covering various regulations of SEBI, IRDA, AMFI etc. Handling Compliance with above mentioned regulations pertaining to Mutual Fund & Insurance Distribution Business of the Bank. Circulating action points arising out of regulatory circulars/notifications/communications and pro-active follow up with the stakeholders ensuring timely implementation of the same. Reviewing existing and new processes and handling correspondences with the regulators on Compliance related matters. Handling Onsite Regulatory Inspections of SEBI, IRDA. Providing clarifications on queries raised by stakeholders within the Bank and from Group entities on Compliance related matters. Drafting and vetting of various submissions to be made to the ACB/Board. Submission of various regulatory reports from time to time. Need to interaction with various regulatory authorities viz. SEBI, IRDA. Need to interact with the middle management and senior management of the Bank.,

As an In Process Sr. QA Engineer, your main responsibilities will include: - Inspecting the product at each machine and checking FG parts located at the machine. - Conducting inspections during the moulding process and documenting the findings in the first part approval columns of the hourly production report/time check sheet. - Providing setup approval after every mould change and communicating with the moulding production personnel regarding any abnormalities. - Offering necessary limit samples on the machines post setup approval. - Identifying any non-conformities observed during inspection, segregating suspected materials with proper identification in the relevant area, raising NCR, and discussing the issues with the shift engineer or supervisor for resolution. - Managing the disposition of hold materials located in the Hold Area within the same shift. - Organizing PQ meetings on the shop floor. - Implementing 5S kaizen and other improvement activities. - Ensuring the calibration of required measuring instruments and gauges, and handing over the measuring instruments to the lab in charge for correction or calibration. - Conducting SPC and gauge R&R activities on a daily basis as per the production plan. - Providing trial part feedback to the concerned individuals, documenting the feedback, and communicating the same to others. - Ensuring the presence of documents and standards at the moulding machine. - Verifying MTC and HRTC functioning with the moulding machine during inspections and other process parameters. - Arranging inspector manpower for 100% inspection at required stages. - Participating in and/or leading self-inspection activities and regulatory inspections. This is a full-time position that offers benefits such as Provident Fund. The work schedule is on a day shift basis. The preferred education requirement for this role is a Diploma, and having 1 year of total work experience is preferred. The work location is in person.,

Cyano Pharma Pvt Ltd is a leading pharmaceutical organization in INDORE (MP) focused on quality, compliance, and innovation. We are looking for a highly skilled professional with strong expertise in Quality Management Systems (QMS) and Validation & Qualifications to ensure compliance with international regulatory standards (WHO, USFDA, EMA, MHRA). Key Responsibilities: Quality Management System (QMS): - Implement, maintain, and continuously improve the site Quality Management System in line with global regulatory guidelines (WHO, USFDA, EMA, MHRA). - Prepare, review, and update SOPs, quality manuals, and quality policies. - Manage change control, deviation, incident reporting, and risk management systems. - Coordinate and support internal, external, and third-party audits, ensuring timely CAPA implementation and closure. - Monitor and analyze quality metrics to drive continuous improvement initiatives. - Provide training and awareness programs for QMS procedures and GMP compliance across teams. - Act as a key contact for regulatory inspections and customer audits. Validation & Qualifications: - Prepare and execute qualification protocols (IQ/OQ/PQ) for equipment, utilities, facilities, and systems. - Lead process validation, cleaning validation, and computer system validation as per regulatory requirements. - Develop and maintain the Validation Master Plan (VMP). - Ensure periodic requalification and revalidation activities are performed according to schedules. - Review and approve all validation-related documents, including protocols and reports. - Ensure all validation activities comply with cGMP, data integrity, and documentation requirements. - Work closely with cross-functional teams (engineering, production, QC) to ensure smooth validation and qualification processes. Qualifications & Experience: - M.Pharm with 9-10 years of experience in Quality Assurance within the pharmaceutical industry. - Strong hands-on experience in QMS implementation and validation/qualification activities. - In-depth knowledge of global regulatory requirements (WHO, USFDA, EMA, MHRA). - Strong communication, documentation, and audit-handling skills. - Proficiency in MS Office (Word, Excel, PowerPoint) and quality documentation systems. - Location: Indore Benefits: - Competitive salary and performance-based incentives. - Opportunity to work on global compliance and regulatory projects. - Exposure to international audits and career advancement opportunities.,

The role requires you to manage Regulatory Compliance for the Bank's third-party products distribution business, such as insurance and mutual funds. Your responsibilities include ensuring compliance with regulations from SEBI, IRDA, AMFI, and handling regulatory inspections. You will be responsible for reviewing processes, communicating regulatory updates, and providing clarifications to stakeholders. Additionally, you will draft submissions to the ACB/Board and submit regulatory reports as needed. Interacting with regulatory authorities and the Bank's management is a key aspect of this role.,

As Manager 2 in the Corporate Quality department at SUN Pharma, you will be responsible for overseeing the quality aspects of contract manufacturing organizations (CMOs) involved in manufacturing site transfer products for the US market. Your primary focus will be to ensure compliance with SUN Pharma Quality and Compliance Standards as well as global regulatory requirements. Your essential job functions will include monitoring and overseeing activities at CMO sites to ensure adherence to SUN Pharma standards and regulatory guidance. You will conduct regular oversight visits, prepare visit reports, and serve as the main point of contact for coordination between SUN site, commercial team, corporate quality audit, and CMO site on manufacturing and technical matters. Additionally, you will be involved in authoring and reviewing quality agreements, ensuring the use of qualified service providers, participating in process validation batches, reviewing quality system documents, conducting visits based on market complaints/recalls/CAPA, reviewing batch records, stability data, and analytical reports, as well as preparing and reviewing SOPs. Your role will also include participation in the initial evaluation of CMOs, supporting regulatory audits at CMO sites, engaging in critical investigations, initiating QMS documents, preparing for regulatory agency inspections, participating in product release site audits, maintaining audit-related documents, preparing monthly reports, staying updated on regulations through training, and following Corporate Quality Policies/Global Quality Standards and Regulatory Guidelines. To be successful in this role, you should have an M.Sc./B.Pharm/M.Pharm or equivalent degree along with a total of 10 years of industrial experience and knowledge. You will also be expected to participate in and execute project work assigned by your reporting authority. If you are looking for a challenging opportunity to ensure quality compliance in contract manufacturing organizations and contribute to the overall quality standards of SUN Pharma, this role is ideal for you. Join us in our mission to maintain high-quality standards and regulatory compliance in the pharmaceutical industry.,

As a Cloud Ops professional at Tally, you will be part of a team dedicated to delivering top-notch connected services in public clouds for Tally's customers. Your mission will be to ensure unmatched reliability, strong security, and optimal cost efficiency. You will have the opportunity to design, implement, and operationalize solutions using cutting-edge cloud native technologies to provide a seamless experience for our customers. Your responsibilities will include overseeing Risk Management & Governance for Tally's suite of cloud-based connected services, implementing secure access at every level, and ensuring compliance with regulatory requirements. You will focus on Cloud Security Oversight, primarily in the AWS environment, while also considering multi-cloud environments. Your role will involve managing regulatory and compliance issues and providing governance and reporting on cloud operations. To excel in this role, you should bring experience in risk management, governance, or compliance roles within fintech, banking, or cloud-centric organizations, particularly in product or fully hosted service-based settings. You should have expertise in AWS security tools, architectures, and best practices, along with a deep understanding of Indian financial sector regulations such as RBI, SEBI, and the IT Act. Possessing relevant certifications like CISSP, CISM, AWS Certified Security Specialty, CRISC, or CISA would be advantageous. You will be expected to demonstrate a thorough understanding of cloud-native security principles, AWS best practices, risk frameworks (NIST, ISO, COBIT), and regulatory mandates. Your role will involve bridging business requirements with technical security implementations, requiring strong communication, stakeholder management, analytical thinking, and a proactive problem-solving approach. Join us at Tally, where we value honesty, integrity, a people-first culture, excellence, and impactful innovation. Be a part of our journey to simplify the lives of millions of small and medium businesses globally through technology and innovation.,

The role requires you to handle Regulatory Compliance for the Bank's third-party products distribution business, including insurance and mutual funds. You will be responsible for ensuring compliance with regulations set by SEBI, IRDA, AMFI, and other regulatory bodies. Your core responsibilities will include overseeing compliance with regulations related to Mutual Fund & Insurance Distribution Business, disseminating action points from regulatory circulars, and ensuring timely implementation. You will review and update processes, manage correspondences with regulators, and facilitate Onsite Regulatory Inspections by SEBI and IRDA. Additionally, you will provide clarifications on compliance queries, draft submissions for ACB/Board, and submit regulatory reports as required. The role also involves interacting with regulatory authorities such as SEBI and IRDA, as well as collaborating with middle and senior management within the Bank. Overall, the position entails a strategic focus on Regulatory Compliance and proactive engagement with stakeholders to uphold the Bank's compliance standards effectively.,

You are invited to a Walk-In Interview at Zydus Corporate Park in Ahmedabad on Saturday, 28th June 2025, from 10:00 AM to 03:30 PM. Zydus is a global healthcare provider focused on innovation and committed to enhancing healthcare therapies to create healthier communities worldwide. ### SAP S/4 HANA Opportunities: 1. **SAP FICO Consultant:** - **Experience:** Minimum 5 years in SAP FI, FM, PS, CO, and S/4HANA. - **Education:** BE/BTech/MCA in IT/Computer/Graduate & SAP Certification is an added advantage. - **Location:** Ahmedabad. - **Profile:** Responsible for designing and implementing SAP FI/FM solutions, integrating with MM, SD, and PPQM modules, and driving process improvements. 2. **SAP ABAP Developer:** - **Experience:** Minimum 5 years in OOABAP, SmartForms, IDocs, and SAP HANA. - **Education:** BE/BTech/MCA in IT/Computer/Graduate & SAP Certification is an added advantage. - **Location:** Ahmedabad. - **Profile:** Design, develop, and optimize ABAP programs supporting SAP applications. 3. **SAP MM/WM Consultant:** - **Experience:** 5 - 8 years with S/4HANA, knowledge of warehouse management is advantageous. - **Education:** BE/BTech/MCA in IT/Computer/Graduate & SAP Certification is an added advantage. - **Location:** Ahmedabad. - **Profile:** Drive SAP MM implementations and integrations with SD, PP, QM, WM, and FI modules. 4. **SAP BW Consultant:** - **Experience:** 5 years. - **Education:** BE/BTech/MCA in IT/Computer/Graduate & SAP Certification is an added advantage. - **Location:** Ahmedabad. - **Profile:** Expertise in SAP BW and BO, strong development and maintenance skills, knowledge about SAP Process, and excellent communication skills. ### Microsoft Technology Opportunities: 1. **Full Stack Developer (Dotnet + Angular):** - **Experience:** 5-7 years with Azure DevOps, AKS, and Microsoft SQL Server. - **Education:** BE/BTech/MCA in IT/Computer. - **Location:** Ahmedabad. - **Profile:** Design and develop scalable solutions using .NET Core, Angular, and MS SQL. 2. **Dotnet Developer / ASP.NET Developer:** - **Experience:** 5-8 years with .NET Framework, IIS, WCF, and MS SQL Server. - **Education:** BE/BTech/MCA in IT/Computer. - **Location:** Ahmedabad. - **Profile:** Design and develop robust solutions using ASP.NET WebForms, MVC, and Core technologies. 3. **Sharepoint Developer:** - **Experience:** 6-12 years with Office 365, remote event receivers, and SharePoint migrations (2010-2016). - **Education:** BE/BTech/MCA in IT/Computer. - **Location:** Ahmedabad. - **Profile:** Design and develop solutions using SharePoint Online, SPFx, React, PowerApps, and Power Automate. ### Infrastructure & Compliance: 1. **IT CSV (Computer System Validation):** - **Experience:** 3-5 years. - **Education:** BE/BTech/MCA in IT/Computer. - **Location:** Ahmedabad. - **Profile:** Role involves 24x7 user access management, maintaining Privilege and User Access Matrices, handling IT QMS activities, supporting software assessments, network maintenance, conducting risk-based failure tests, and representing IT processes during audits and regulatory inspections. This walk-in interview is for experienced professionals. Freshers are encouraged to apply online for future opportunities. Priority will be given to candidates who can join immediately and are willing to relocate to the job location. For more information about Zydus, visit [Zydus Website](https://www.zyduslife.com/zyduslife/).,

As a key resource within the Audit Management Office (AMO), you will ensure effective coordination and management of audits and inspections involving Data, Digital & IT (DD&IT) systems and processes. This includes supporting GxP audits (e.g., GMP, GCP) and regulatory inspections by authorities such as FDA, EMA, MHRA, and Swissmedic. Your role as an associate will involve acting as a liaison, ensuring that relevant DD&IT subject matter experts address audit queries and deliver required documentation in a timely and accurate manner. Additionally, you will be responsible for monitoring audit findings, overseeing remediations, and driving continuous improvement in audit readiness. Govern processes to effectively manage both internal and external audits across Data, Digital & IT (DD&IT), focusing on GxP (e.g., GMP, GCP), quality, and regulatory-related audits. Act as the single point of contact (SPOC) for audit teams across DD&IT, coordinating audit and inspection activities, ensuring effective communication, and maintaining compliance throughout the process. Notify and mobilize relevant DD&IT stakeholders for audits and inspections, ensuring timely readiness. Coordinate globally with business teams to ensure audit support tickets are created, tracked, and resolved in alignment with Novartis policies and procedures. Conduct pre-audit meetings to clarify IT scope, agree on auditor pre-requests, align timelines, and ensure stakeholders understand expectations for audits and inspections. Provide advice and guidance to DD&IT teams on GxP and information systems compliance requirements to ensure alignment with regulatory standards such as FDA, EMA, MHRA, and Swissmedic expectations. Guide DD&IT SMEs by clarifying audit process requirements and supporting them throughout the audit lifecycle, ensuring accurate delivery of requested information. Collaborate with internal teams to improve and standardize governance frameworks and processes, aiming to reduce audit findings and improve inspection readiness. Manage relationships at a global level across divisions and functions, facilitating cross-functional alignment and collaboration on audit-related matters. Monitor and report on audit findings, remediation actions, and related improvement activities, ensuring compliance, security, and quality gaps are addressed thoroughly. To be considered for this role, you should have a University degree or equivalent, with a Masters degree in IT, Quality Management, Business Administration, or related fields. You should have overall 8-10 years of work experience in quality management, audit, and compliance within IT, preferably in a global organization. Experience in the pharmaceutical industry or other regulated industries, with knowledge of GxP processes and compliance requirements, is required. Strong communication skills and the ability to manage multiple priorities efficiently are essential for this position. Join Novartis and be part of a mission to reimagine medicine and improve people's lives. Learn more about our commitment to diversity and inclusion and explore the opportunities available within our network.,

Key Responsibilities: Establish, implement, and maintain GMP-compliant quality systems across the API manufacturing unit. Lead and participate in regulatory, internal, and third-party audits ; ensure timely closure of observations and CAPAs. Review and approve validation protocols, master documents, and batch records in line with regulatory requirements. Oversee product release , stability studies, and quality documentation control. Manage and investigate market complaints and implement appropriate corrective actions. Ensure regulatory compliance with international guidelines (e.g., USFDA, EU-GMP, WHO-GMP). Handle vendor audits and qualification for raw materials, packaging materials, and third-party manufacturers. Train and guide the QA team to ensure continuous improvement and inspection readiness. Required Skills & Qualifications: Bachelor's/Master's degree in Pharmacy, Chemistry, or a related field. 812 years of experience in QA roles within API manufacturing , including managerial experience. Strong understanding of GMP , ICH guidelines , and international regulatory frameworks. Proven experience with regulatory inspections (USFDA, MHRA, EUGMP, etc.). Excellent leadership, documentation, and communication skills.

As a Lead-Compliance-Retail Assets in the Compliance department, your main responsibility will be to provide advisory on regulatory expectations to Retail Assets, Credit Cards, and Shared Services business units. You will be expected to coordinate and collate ad-hoc/indent requirements in collaboration with business stakeholders. Additionally, reviewing Policies, SOPs, Manuals from regulatory circulars and advisory perspectives will be part of your role, along with coordinating with officials during RBI Examination exercises for closure of regulatory obligations. Moreover, you will be required to coordinate with stakeholders during Regulatory Inspections and collation of data, assist the Regulatory compliance team for Ad-hoc requirements, and preparation of various Board-related notes. Providing effective advisory to business stakeholders and ensuring delivery timelines are met will also be crucial aspects of this role. To qualify for this position, you should have a Graduation degree in any field, while a Post Graduation degree is also desirable. The ideal candidate will have 10-18 years of experience in compliance-related roles.,

You should have 16-20 years of experience in the pharmaceutical industry and be located in Pithampur. A degree in M.Sc./ M. Pharma / B. Sc. / B Pharma is required for this position. Your responsibilities will include daily planning of analytical activities, resource management, and work allocation. You will be responsible for planning and executing sampling and analysis for raw materials, packaging materials, intermediates, and finished products. You will review and/or approve the implementation of standard operating procedures, analytical protocols, and analytical reports. Additionally, you will review and/or approve the qualification and calibration of instruments. You will investigate and review laboratory events, out-of-specification (OOS) results, out-of-trend (OOT) results, and deviations. Ensuring compliance with QC-related electronic data management, such as computer system validation, electronic data backup, storage, and retrieval, will be part of your role. You will conduct training sessions to enhance the analytical skills of quality control personnel. Managing procurement and inventory control of materials and equipment required for QC activities will be essential. You will review analytical activities related to process validation, cleaning validation, and analytical method validation. You will have the authority to release raw materials, intermediates, stability samples, and working standards in the absence of the QC Head through the Laboratory Information Management System (LIMS). Monitoring non-routine activities such as stability studies, working standard management, calibration management, and analytical method transfer/verification will also be part of your responsibilities. You will be the responsible person for all QC activities in the absence of the Head QC. Desired skills for this position include experience in facing various regulatory inspections like USFDA, MHRA, EMA, and TGA. Experience in auditing finished dose formulation units, API and Intermediate/KSM vendors is preferred. Experience of working in an API unit is a plus. You should have excellent functional knowledge and application skills, a proactive approach to internal and external queries, and the ability to manage multiple stakeholders. High standards of business ethics, excellent communication skills, and strong decision-making skills are essential for this role.,

The Lead-Compliance-Retail Assets position in the Compliance department involves providing advisory on regulatory expectations to Retail Assets, Credit Cards, and Shared Services business units. The main responsibilities include coordinating and collating ad-hoc/indent requirements with business stakeholders, reviewing policies, SOPs, manuals based on regulatory circulars and advisory perspective, coordinating during RBI Examination exercise closure of regulatory obligations, managing stakeholders during Regulatory Inspections and data collation, assisting the Regulatory compliance team with Ad-hoc requirements and preparation of various Board related notes, and providing effective advisory to business stakeholders with a focus on delivery timelines. The ideal candidate for this role should have a Graduation in any field, Post Graduation in any specialization, and 10-18 years of relevant experience.,

As a Clinical Quality Assurance professional at WPPL, you will play a crucial role in ensuring the establishment, implementation, and maintenance of processes required for the Quality Management System. Your responsibilities will include reporting on the performance of the quality system, planning and executing clinical activities, and conducting various audits across departments. You will be responsible for reviewing equipment installation, qualification, calibration, and preventive maintenance in the clinical department, ensuring compliance with relevant SOPs and guidelines. Additionally, you will review clinical data, pharmacokinetic analysis, statistical output, and statistical analysis reports to ensure accuracy and adherence to protocols. As part of your role, you will conduct external vendor audits, review raw data of clinical projects, and perform internal study audits to assess compliance with GCP/GLP, protocols, SOPs, and regulatory requirements. You will also review and evaluate change controls, deviations, CAPAs, and conduct facility assessments at clinical and pathology laboratories. Collaborating with the Head-QA, you will support regulatory inspections and audits, review responses to queries, and ensure timely implementation of CAPA actions based on investigative results. Additionally, you will update policies, quality manuals, SOPs, and work documents, providing valuable insights and comments for their approval. Your role will involve monitoring studies at external CROs, conducting meetings with clinical and pathology laboratory departments to update on quality systems, and taking on other responsibilities as assigned. With your M.Sc, M.Pharm, or Ph.D. qualification and 8-10 years of experience in Clinical Quality Assurance for BA/BE studies, you will report to the Associate Director Quality Function. Join us at WPPL and be part of a mission-driven team dedicated to making a positive impact on global healthcare by ensuring quality and compliance in clinical activities and processes.,

As a Compliance Officer at IndiaP2P, you will play a crucial role in providing legal advice and support to the Management on various ROC/MCA matters. Your responsibilities will include handling ROC/MCA matters, assisting in corporate governance issues, drafting and reviewing contracts, compliance matters, and other legal aspects relevant to corporate operations. You will be expected to conduct regulatory inspections of commodity and stock markets, coordinate internal audits, DP audits, and special/spot inspections, verify data submitted by all departments, and ensure timely submission of suitable replies to regulatory authorities. Additionally, you will assist in implementing circulars issued by regulators and stock exchanges, monitor compliance with KYC and AML/PMLA guidelines, and report suspicious transactions to relevant authorities. Your role will also involve ensuring compliance with trading terminals regulations, maintaining compliance calendars, handling listing compliances with stock exchanges, and filing necessary returns, disclosures, and forms within prescribed timelines. Familiarity with corporate governance principles, securities law compliance, and disclosure requirements will be advantageous. This is a full-time position based in Hyderabad, with occasional travel required. The ideal candidate will have 1 year of experience in compliance management. Health insurance benefits are provided, and the work schedule includes day and morning shifts. Relocation to Hyderabad before the expected start date of 01/08/2024 is preferred.,

As the Quality Management Systems (QMS) Manager at our corporate departments, you will play a vital role in ensuring the highest standards of quality across all aspects of our operations. Your responsibilities will include reviewing, approving, and closing change controls, deviations, and incidents for the corporate department. Additionally, you will be tasked with reviewing change controls for oral dosage forms across all Hetero formulations facilities. Your role will also involve reviewing Process Validations, Continued Process Verification, Cleaning Validations, Hold time studies, and Annual Product Quality Reviews (APQR) across our formulations facilities. You will be responsible for coordinating and overseeing Quality review meetings, as well as implementing and harmonizing the Quality Management system across all oral dosage form facilities. In this position, you will be in charge of issuing and controlling Critical Quality Attribute (CQA) Standard Operating Procedures (SOPs) for the respective formulation units. You will provide support for regulatory inspections in all formulation units within the Hetero group and conduct self-inspections to ensure compliance with quality standards. You will work closely with your supervisor and be ready to take on any additional responsibilities as assigned. Your role is crucial in maintaining and enhancing the quality standards that define our organization.,