Job Title: Associate Manager – Quality Assurance
Location: Chennai, India
Employment Type: Full-time | On Premise
About the Company:
Pfizer is a global leader in pharmaceuticals, dedicated to breakthroughs that change patients’ lives. Pfizer Global Supply (PGS) is responsible for manufacturing and distributing a wide portfolio of medicines with the highest quality and compliance standards.
Role Overview:
The Associate Manager – Quality Assurance will review product development documentation, analytical data, and qualification reports to ensure data integrity, cGMP compliance, and adherence to regulatory guidelines. This role supports sterile product development, inspection readiness, and continuous improvement initiatives, while collaborating with global teams to maintain Pfizer’s high-quality standards.
Key Responsibilities:
Review analytical data (including chromatographic data, audit trails, instrument/equipment qualification) for compliance with SOPs and regulatory requirements.
Ensure adherence to 21 CFR Part 11 and conduct periodic audit trail reviews.
Apply ICH quality guidelines and regulatory standards for microbiology method development (sterility, BET, CCIT, etc.).
Oversee sterility requirements and filter validation in line with PDA technical reports.
Support sterile ANDA product and combination product development requirements.
Perform statistical evaluation and analysis of analytical data during method development and validation review.
Maintain compliance in laboratories and during document review.
Contribute to new QA initiatives, continuous improvement projects, and business line partner collaborations.
Support internal audits, inspection readiness, and regulatory inspections.
Qualifications – Minimum Requirements:
Master’s degree in Chemistry or Pharmacy.
Relevant experience in analytical data review, technology transfer, and cGMP sterile manufacturing.
Strong understanding of cGMP requirements (21 CFR parts 210/211), ICH guidelines, and sterile product regulations.
Awareness of DI (Data Integrity) and ALCOA principles.
Proficiency in MS Office (Word, Excel, PowerPoint).
Strong communication skills, attention to detail, and self-motivation.
Preferred Requirements:
Knowledge of global regulatory guidance on microbiology methods and sterile manufacturing.
Experience in inspection readiness and internal audit processes.
Ability to suggest process improvements and participate in continuous improvement initiatives.
Work Location Assignment: On Premise
Estimated Salary: ₹14–18 LPA (Based on mid-level QA roles in multinational pharma companies in India)
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