Associate Manager position in Manufacturing Quality Assurance at Pfizer's Vizag facility, overseeing cGMP compliance across sterile drug manufacturing operations including filling, washing, and depyrogenation. Requires 6-10 years of pharmaceutical manufacturing QA experience and responsibility for batch record reviews, investigations, and regulatory compliance.

Responsibilities

Ensure cGMP compliance in solution preparation, filling, capping, and collection operations
Review electronic batch records, assess manufacturing exceptions, and audit equipment trails
Conduct daily facility walkthroughs, monitor CCTV feeds, and report non-compliance observations
Perform manufacturing investigations, implement corrective actions, and ensure regulatory alignment
Lead interim team supervision and identify process gaps to improve efficiency and reduce downtime

Requirements

Bachelor's or Master's degree in Pharmacy or related life sciences field
6-10 years of manufacturing quality assurance or production experience in pharmaceuticals
Knowledge of GMP regulations and sterile product manufacturing standards
Capability to handle regulatory inspections from FDA, MHRA, TGA and similar agencies
Technical writing skills for accurate and concise documentation
Proficiency with quality investigation tools and batch record systems
Strong interpersonal and written communication abilities across organizational levels

Associate Manager - MQA upstream

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