QA Sterile Assistant Manager

• 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.

Required Experience:

Manager