أخصائي أول ضمان الجودة

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.

Required Educational Level and Certificates : Bachelor Degree in Pharmacy, Science, Medicine or Chemistry

Required Experience : 5- 7 years of experience in a similar position