Quality Assurance Sr. Executive

• Review the batch record and identify any incomplete data and calculations, ensure that its content is completed and all process complies with the approved procedures.
• Check that any OOS, NCMR / Deviation, Change request related to the batch are recorded,investigated and disposed properly.
• Supervise QA In-process team for line Clearance, In-process checks and shop floor activities.
• Communicate to the different concern departments any findings observed during batch record audit.
• Report for any deviation observed during batch record audit.
• Decide the release or rejection of the batch based on careful evaluation of relevant documents.
• Provide active support to QA team for execution of validation and QMS functions.
• Communicate with SFDA for any query or response on regulatory related question.
• Managing activities related to controlled drugs as per SFDA guidelines including new manufacturing requests, new transfer requests and destruction requests.
• Registration of released finished goods batches in the IBRCS (Importing, Batch Release and Clearance System) as per Saudi Food and Drug requirements.
• Registration of released finished goods batches in SFDA RSD system.
• Submit the batch record to Document Control for archiving after reviewing and releasing are completed.

• A minimum of 03 years experience in same operation of pharmaceutical .
• Master’s degree / Bachelor degree in Pharmacy.
• Professional Classification & Registration from SCFHS
• Knowledge of manufacturing instruments, equipment. PK and analytical studies are required.
• Excellent interpersonal, communication skills and team playing capability and ability to meet challenges and deadlines.
• Fluency in Arabic & English languages.

Jamjoom Pharma