Associate Manager - Manufacturing Quality Assurance (Upstream)
By Admin · Quality Assurance & Quality Control
ROLE OVERVIEW
This Associate Manager - MQA Upstream role at Pfizer’s Vizag sterile manufacturing site is a critical quality leadership position supporting cGMP compliance across solution/emulsion preparation, vial and ampoule washing, depyrogenation, filling, capping, and collection. The position safeguards patient safety and product quality for Pfizer’s sterile injectable portfolio, where regulatory scrutiny from USFDA, MHRA, and TGA is intense. By reviewing electronic batch records, assessing AMPS exceptions, overseeing alarm and trend reports, and investigating deviations, the MQA professional ensures every batch meets Pfizer standards and global regulatory expectations. This is a compelling opportunity for experienced QA professionals to deepen expertise in sterile manufacturing, electronic batch systems, and inspection readiness while influencing shop-floor quality culture, process simplification, and continuous improvement at one of Pfizer’s key India sites.
ROLE DEFINITION & RESPONSIBILITIES
- •Ensure cGMP compliance for solution and emulsion preparation, vial and ampoule washing, depyrogenation, filling, capping, and collection operations.
- •Review electronic batch records (eBR) and assess AMPS exceptions, batch reports, and equipment audit trails with technical inputs.
- •Perform alarm impact assessments and review/approve trend reports to maintain validated process control and data integrity.
- •Monitor start-up and in-process activities, perform CCTV oversight, and conduct daily cleanroom walkthroughs against approved SOPs and batch records.
- •Lead manufacturing investigations, implement CAPA, and ensure timely closure, aligning outcomes with regulatory and site requirements.
- •Assess equipment breakdowns and troubleshoot manufacturing issues to protect product quality, patient safety, and uninterrupted supply.
- •Support regulatory, corporate, and internal audits or inspections, including data collection, investigator support, and inspection readiness.
- •Review and approve master recipes, workflows, and master data such as graphs, classes, and entities within the AMPS platform.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- B.Pharm / M.Pharm / M.Sc. in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related life-sciences discipline.
- 6–10 years’ experience in Manufacturing Quality Assurance, Quality Assurance, or Production within a pharmaceutical manufacturing facility.
- Hands-on experience in sterile injectable manufacturing processes, aseptic techniques, and cGMP operations.
- Demonstrated capability in handling regulatory inspections such as USFDA, MHRA, or TGA.
- Strong technical writing skills for investigations, batch record reviews, SOPs, and CAPA documentation.
- Working knowledge of quality tools, root cause analysis, and manufacturing investigation methodologies.
- Experience with electronic batch records, AMPS, or similar electronic manufacturing systems preferred.
PREFERRED QUALIFICATIONS
- •Master Recipe & Workflow Review
- •CCTV Monitoring for Quality Oversight
- •Equipment Audit Trail Review
- •Data Integrity Principles
- •Lean/Continuous Improvement in Pharma Manufacturing
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
Pfizer Inc. is an American multinational pharmaceutical and biotechnology corporation. It is dedicated to the discovery, development, manufacturing, marketing, and sale of medicines and vaccines worldwide. The company focuses on breakthrough science to deliver innovative treatments across various therapeutic areas to improve health outcomes.
EXPECTED CAREER ROADMAP
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