Senior Quality Assurance
Skills
About This Role
1. Line Clearance Oversight
Execute and verify line clearance procedures within production areas to prevent cross-contamination and ensure readiness for manufacturing.
2. Process Stage Approval
Authorize start-up of production activities based on compliance verification.
3. Comprehensive Sampling
Manage the sampling process for In-process, Finished Products, Control Samples, and Cleaning Validation to ensure representative data collection.
4. In-Process Control (IPC) & Documentation
Perform in process control checks and documentation in the related manufacturing records.
5. Packaging & Labeling Approval
Approve specimens for secondary packaging materials, including Alu.foil, cartons and leaflets.
6. Validation Execution
Oversee the execution of Process Validation batches, ensuring all parameters are monitored and recorded according to the validation protocol.
7. Cleaning Validation & Verification
Conduct sampling and verification for cleaning validation protocols to ensure the effectiveness of equipment decontamination.
8. Final Product Inspection
Perform final physical and documentation inspections of finished goods to ensure they meet all release specifications.
9. Inventory & SAP Management
Manage the transfer of finished goods within the SAP system, ensuring data accuracy between physical stock and digital records.
10. Quality Event Support
Provide technical expertise in managing Quality Events, including Deviations, CAPAs, and Change Control processes.
11. Specialized Handling of Potent Materials
Demonstrate expertise in the manufacturing and handling of High-Potency materials ensuring strict adherence to containment strategies, safety protocols.
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