Quality Assurance Job at Pfizer | Apply Now for the Associate Manager Role
Pfizer is hiring an Associate Manager – Quality Assurance for its facility in Chennai, Tamil Nadu. This Quality Assurance Job position is designed for a Master of Pharmacy (M.Pharm) or M.Sc. Chemistry graduates with significant experience in analytical data review and cGMP pharmaceutical sterile manufacturing. The successful candidate in this Pfizer Job will oversee documentation related to product development, manage 21 CFR Part 11 compliance for electronic records, and lead Data Integrity (DI) initiatives using ALCOA principles. This position offers the opportunity to support sterile ANDA product development and combination products within a world-class Quality Operations team.
- Job Title: Associate Manager Quality Assurance
- Locations: India – Chennai
- Job Requisition ID: 4939724
About Pfizer
Pfizer is one of the world’s premier biopharmaceutical companies, dedicated to discovering, developing, and manufacturing life-saving medicines and vaccines. Through the Pfizer Global Supply (PGS) network, the company ensures that its diverse portfolio of pharmaceutical products is manufactured to the highest quality standards and reaches patients globally with efficiency and reliability. In Chennai, Pfizer operates state-of-the-art facilities, including a significant presence at the IIT Madras Research Park, where teams focus on sterile product development, technology transfer, and rigorous quality operations to meet international regulatory requirements.
Quality Assurance Job Summary
- Responsible for reviewing documents related to product development, analytical data (including electronic data, chromatographic data, and audit trails), as well as instrument and equipment qualification in relation to Quality Assurance Jobs.
- Accountable for ensuring data integrity compliance and adherence to SOPs during the review of both hard copy and electronic records. Conduct periodic system audit trail reviews and ensure compliance with 21 CFR Part 11 requirements.
- Liaise effectively with global BL and OQ colleagues to achieve organizational objectives. Maintain a thorough understanding of ICH quality guidelines and relevant regulatory guidance on microbiology method development pertaining to sterility, BET, CCIT, and associated development requirements.
- Possess in-depth knowledge regarding sterility requirements and filter validation activities in accordance with PDA technical reports.
- Demonstrate familiarity with requirements for sterile ANDA product development and combination products. Exhibit strong proficiency in MS Office applications, including Excel, Word, and PowerPoint presentation preparation.
Responsibilties
- Awareness of DI and ALOCA principles. Basic understanding of cGMP requirements, including 21 CFR parts 210 and 211, ICH guidelines, and sterile product requirements. Maintain compliance in laboratories and during document review, especially crucial for any Quality Assurance Job.
- Ability to perform statistical evaluation and analysis of analytical data during method development and validation review.
- Effective communication skills. Adherence to discipline and self-motivation. Participate in the implementation of new initiatives and goals within the QA function and with business line partners to support consistency, efficiency, and compliance.
- Manage time to meet agreed targets and plan work activities for projects within assigned teams. Suggest improvements and participate in continuous improvement activities.
- Contribute to the development and compliance of quality and business line partner procedures. Provide support for inspection readiness efforts, internal audits, and regulatory inspections as required for your Quality Assurance Job role.
Requirements
Education:A
Master of Pharmacy is required for the Pfizer Job
Relevant Experience:
Relevant work experience in an analytical data review and technology transfer, and a cGMP pharmaceutical sterile manufacturing area.
