About the role
Documentation & Document Control: Manage the complete lifecycle (preparation, issuance, retrieval, and destruction) of all QA documents, including SOPs, Logbooks, BMRs, and BPRs, while maintaining the documentation cell. In-Process Quality Assurance (IPQA): Conduct line clearances, perform in-process checks, and execute Acceptable Quality Level (AQL) inspections across general manufacturing, packing, and aseptic areas. Aseptic Area Oversight & Media Fills: Provide strict QA oversight during aseptic processing, manage aseptic process simulations (media fills), and prepare related protocols, trend reviews, and personnel tracking matrices. Sampling & Dispensing Verification: Oversee sample collection for commercial, submission, and validation batches, and rigorously verify the dispensing of raw and packaging materials. Shop-Floor Compliance & Environmental Monitoring: Ensure strict cGMP compliance through frequent shop-floor rounds, monitor environmental controls/cleanliness, and verify routine equipment printouts (CIP/SIP, Autoclaves, incubators). Validation & Qualification Execution: Actively participate in the preparation and execution of Process Performance Qualifications, Cleaning Validation protocols, Hold Time studies, and Master Formula Records (MFR). Product Reviews & Audit Trails: Prepare Annual Product Quality Reviews (APQR), inspect finished product consignments, manage control samples, and review equipment audit trails for both aseptic and non-aseptic areas.