Associate Manager - Quality Assurance (Batch Release)
By Admin · Quality Assurance & Quality Control
ROLE OVERVIEW
Pfizer’s Vizag manufacturing site plays a critical role in supplying sterile injectable medicines to patients across regulated global markets. As Associate Manager – Quality Assurance (Batch Release), you will act as a key gatekeeper in the product disposition process, ensuring every batch is reviewed, investigated, and released in full compliance with cGMP, GDP, marketing authorisations, and Pfizer’s science- and risk-based quality culture. This position matters because batch release directly protects patient safety, maintains supply continuity, and supports regulatory inspection readiness. You will collaborate across manufacturing, QC, engineering, and supply chain to resolve quality holds and documentation gaps. For experienced QA professionals, this is a compelling opportunity to deepen sterile injectable expertise, work with electronic batch records and SAP/gLIMS, and grow into senior quality leadership within a global pharmaceutical leader.
ROLE DEFINITION & RESPONSIBILITIES
- •Review electronic and manual batch records to confirm audit items are complete and approved per Pfizer policies, procedures, and cGMP expectations.
- •Verify expiration dates and batch-specific details against marketing authorisation, regulatory commitments, and approved manufacturing instructions before disposition.
- •Confirm all deviations, investigations, CAPAs, and quality holds are closed and appropriately dispositioned before batch release.
- •Track quality restrictions, holds, and release status in relevant systems, escalating ageing or unresolved items to QA management.
- •Interface with manufacturing, QC, engineering, and supply chain disciplines to gather missing information, correct documentation errors, and facilitate lot release.
- •Ensure strict adherence to safety procedures, GMP, GDP, and data integrity requirements throughout batch review and release activities.
- •Support audit and inspection preparation by maintaining inspection-ready records, responding to queries, and participating in regulatory or internal audits.
- •Contribute to continuous improvement of batch release workflows, metrics, training, and EHS responsibilities as defined by site management.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- B.Pharm, M.Pharm, or MSc in a relevant scientific discipline.
- 8–10 years of experience in manufacturing quality, quality control, production, or QA within a pharmaceutical manufacturing facility.
- Hands-on experience with sterile injectable manufacturing and batch release processes.
- Working knowledge of cGMP, GDP, data integrity, and regulatory audit expectations.
- Excellent technical writing, communication, and presentation skills for cross-functional and inspection interactions.
- Proficiency in Microsoft Office, Microsoft Project, and statistical software for trend review and reporting.
- Demonstrated ability to apply quality principles, organizational precedents, and regulatory expectations to routine and complex release decisions.
PREFERRED QUALIFICATIONS
- •SAP, gLIMS, and AMPS experience
- •AI tools such as ChatGPT or Microsoft Copilot for responsible productivity and problem-solving
- •Mentoring and training colleagues
- •Strong analytical and problem-solving skills
- •Ability to adapt to changing priorities and manage multiple tasks simultaneously
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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