Associate Manager – Manufacturing Quality Assurance
By Admin · Quality Assurance & Quality Control
ROLE OVERVIEW
Pfizer’s Associate Manager, Manufacturing Quality Assurance, based in Visakhapatnam, is a critical cGMP compliance role supporting terminal sterilization, visual inspection and packaging operations. The position ensures that manufacturing processes, batch records and equipment systems remain inspection-ready for global regulators such as USFDA, MHRA and TGA. This is not a generic QA job: it directly protects patient safety, product quality and Pfizer’s commercial supply continuity. The role offers a strong platform for experienced pharma QA professionals to deepen expertise in sterile operations, electronic batch record review, deviation/AMP impact assessment and audit management. With Pfizer’s science- and risk-based quality culture, the successful candidate gains exposure to advanced manufacturing systems, cross-functional troubleshooting and process simplification, making it an excellent long-term career move within global pharmaceutical operations.
ROLE DEFINITION & RESPONSIBILITIES
- •Ensure operating state of cGMP compliance across terminal sterilization, visual inspection and packaging operations.
- •Review electronic batch records (eBR), batch reports and equipment audit trails, assessing AMP exceptions with technical support from the Senior Team Leader.
- •Perform Acceptable Quality Level (AQL) sampling and inspection, recording results accurately in batch records for all commercial products.
- •Execute batch start-up and end activities, including sensor challenge tests, recipe review and validation of AMPS recipes.
- •Conduct random process checks and daily floor walkthroughs, documenting observations and escalating quality risks to the Senior Team Leader.
- •Assess equipment breakdowns, alarms and quarterly alarm trends for impact on product quality, patient safety and batch disposition.
- •Support regulatory, corporate and internal audits/inspections, maintaining inspection-ready documentation and cGMP compliance.
- •Identify gaps and drive process/procedure simplification to reduce downtime, increase efficiency and strengthen quality systems.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor’s degree in Pharmacy (B.Pharm), Master’s (M.Pharm) or MSc in a relevant pharmaceutical/life sciences discipline.
- 6–8 years of hands-on experience in Manufacturing Quality Assurance, Quality Assurance or Production within an FDA-approved pharmaceutical manufacturing facility.
- Fundamental knowledge of terminal sterilization processes, visual inspection and packaging operations.
- Demonstrated experience handling regulatory, corporate and internal inspections such as USFDA, MHRA and TGA.
- Proven ability to review batch records, electronic batch records (eBR), equipment audit trails and investigate manufacturing exceptions.
- Strong understanding of sterile operations, equipment alarms, deviation/AMP impact assessment and quality risk management.
- Effective communication, decision-making and cross-functional collaboration skills across all organizational levels.
PREFERRED QUALIFICATIONS
- •Quality Administered Systems (e.g., TrackWise, Veeva Vault Quality)
- •AI Tools for Productivity (ChatGPT, Microsoft Copilot)
- •Mentoring and Reviewing Colleagues’ Work
- •Strong Organizational Skills and Attention to Detail
- •Risk Management and Ethical AI Use
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
APPLICATION ADVISORY
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.