Position : QA OFFICER / QA EXECUTIVE
Experience Required: 0-2 years / 5-8 years
Key Responsibilities (For Both Experience Levels) A. In-Process Quality Control (IPQC) ? Perform in-process checks during manufacturing and packing. ? Monitor critical parameters of Tablet, DPI, Liquid Injection & Dry Injection sections. ? Record results in real-time as per GMP guidelines. ? Coordinate with production for any process deviations or non-conformities. ? Verify line clearance before start of manufacturing or packing. B. Documentation ? Maintain and review batch manufacturing records (BMR) and batch packaging records (BPR). ? Ensure all entries are in compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate). ? Support preparation and issuance of controlled documents. ? Ensure proper documentation flow from production to QA. C. SOP Review & Control ? Review existing SOPs and update as per regulatory requirements. ? Assist departments in drafting new SOPs
Maintain SOP distribution, archival, and document version control. ? Ensure compliance of all departments with updated SOPs. D. Compliance & GMP Monitoring ? Monitor hygiene, gowning, and GMP practices on the shop floor. ? Ensure adherence to cleaning and sanitization schedules. ? Report deviations, change controls, and support CAPA documentation. E. BMR / BPR Review ? Check completeness of BMR/BPR before batch release. ? Ensure corrections, overwriting, and entries follow GDP compliance. ? Coordinate with QC for batch release documentation.
Job Type: Full-time
Pay: ?16,000.00 - ?35,000.00 per month
Work Location: In person
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