QA - Sr.Executive HLL-IX

Position: Senior Executive – Quality Assurance Department: Quality Assurance Location: HLL-IX, Andhra Pradesh Industry: Pharmaceutical Manufacturing Key Responsibilities: Ensure compliance with cGMP, GLP, SOPs, and regulatory requirements . Perform shop-floor QA activities , including line clearance and batch documentation review. Review BMR/BPR, SOPs, protocols, specifications, and validation documents . Initiate and investigate deviations, OOS/OOT, incidents, complaints, and CAPA . Manage change controls and ensure timely implementation and closure. Coordinate with Production, QC, Engineering, and other departments for quality-related activities. Support internal, customer, and regulatory audits and ensure effective CAPA implementation. Ensure data integrity and good documentation practices (GDP) . Monitor compliance with manufacturing, cleaning, environmental, and validation requirements. Prepare and review QA reports and maintain quality-system records. Qualification: B.Pharm/M.Pharm/M.Sc. or equivalent. Experience: Typically 3–10 years in Pharmaceutical QA , preferably in API/formulation manufacturing. Skills: Strong knowledge of GMP, documentation, investigations, CAPA, change control, audit handling, communication, and problem-solving.