Associate Manager - MSAT (Commissioning & Qualification)
By Admin · Quality Assurance & Quality Control
ROLE OVERVIEW
Pfizer’s Manufacturing Science & Technology (MSAT) group at Vizag plays a critical role in commissioning, qualification and validation of sterile injectable manufacturing assets. The Associate Manager – MSAT (C&Q) ensures equipment, utilities, facilities and processes are qualified to cGMP, FDA and Pfizer Quality Standards, directly protecting product sterility, patient safety and regulatory compliance. This position matters because Vizag supports regulated-market injectables, where robust validation underpins every batch release. The role offers exposure to complex sterile processes, cleaning validation, computer system validation, audits and technology transfers. For pharma professionals with QA, validation or sterile manufacturing experience, it is a compelling opportunity to deepen technical expertise, work cross-functionally and influence compliance strategy at a global scale while building a pathway toward senior quality and MSAT leadership.
ROLE DEFINITION & RESPONSIBILITIES
- •Review, approve and maintain validation master plans, protocols, reports, traceability matrices and qualification documents for sterile manufacturing equipment and utilities.
- •Execute and oversee DQ, FAT/SAT, IQ, OQ, PQ and spreadsheet qualification activities, ensuring timely revalidation within established intervals.
- •Troubleshoot validation and qualification issues for autoclaves, vial washing, depyrogenation tunnels, filling, stoppering, sealing, inspection and packing equipment.
- •Perform statistical analysis of testing results, alarm assessments, process anomalies and data trends to support quality investigations and root-cause decisions.
- •Manage quality systems including change control, deviations, CAPA, documentation, quality agreements and investigations using DMAIC and risk-based tools.
- •Coordinate validation execution with cross-functional teams, integrate schedules into production, and support cleaning validation and product transfer activities.
- •Represent engineering validation during regulatory audits, prepare compliance responses and ensure alignment with 21 CFR Part 11, GAMP, ISO and PDA guidance.
- •Mentor colleagues, review technical reports and drive continuous improvement, safety awareness and inspection readiness across the Vizag site.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- B.Pharm, M.Pharm, B.Tech or BE in Pharmaceutical Sciences, Engineering or related discipline.
- 6–8 years in Quality Assurance, Validation, Engineering or Production within sterile dosage form facilities.
- Proven expertise in cGMP, FDA regulatory guidelines, ICH-Q, 21 CFR Part 11 and data integrity principles.
- Hands-on experience qualifying sterile injectable equipment, utilities, facilities, cleaning processes and CSV systems.
- Strong knowledge of GAMP, PDA guidance, ISO standards, component assessment and calibration of validation instruments.
- Excellent verbal and written communication, document review, data analysis and cross-functional coordination skills.
- Ability to work independently, manage short-term plans and support regulatory audits and investigations.
PREFERRED QUALIFICATIONS
- •PDA Technical Reports
- •ISO Standards
- •AI Tools (ChatGPT/Microsoft Copilot)
- •Medical Device Validation
- •Mentoring & Training
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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