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QA - Sr.Executive HLL-IX

Hetero · Guntur, Andhra Pradesh, India - Nellore, Andhra Pradesh, India - Vijayawada, Andhra Pradesh, India - Rasapūdipalem, Andhra Pradesh, India

4–10 yrs experiencefull_timePosted 2w ago

Job description

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 310 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. Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

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