Senior Quality Assurance

Responsibilities

• 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.

• Bachelor Degree in Pharmacy, Science, Medicine or Chemistry.
• 5-7 years of experience in a similar position.