Quality Assurance Assistant (Pharmaceutical)
PNet (Pty) Ltd
Southern Suburbs
8d ago

Quality Assurance QUALITY ASSURANCE 1. Packing List Logging of information as per the packing list received from supply chain.

Evaluation of COA’s received from the manufacturer and filing both electronically and as a hard copy. Notifying the QA pharmacist of any out of specifications on the COA’s, Capture data for trend analysis (COA’s and retest results) 2.

Samples Inspection of samples against Master Sample Report Forms. Ensure the correct storing of the retention samples. ?

Maintain the sample room which includes daily temperature logging and monitoring calibration service dates. ? Reference standard control and ordering.

  • Liaise with third party distributors regarding dispatch of samples for retesting. 3. Audits ? Prepare audit programs annually under supervision of the QA pharmacist.
  • Compile all relevant documentation for audits. ? Schedule all audit preparation meeting times with QA pharmacist. ? Accompany and assist the lead auditor on both internal and external audits.
  • Assist with the compilation and review of all audit reports and findings. 4. Batch documentation ? Prepare annual schedules for batch documentation requests from APL India.
  • Request batch documents from APL India in accordance with the schedule. ? Review all batch documents and prepare a deficiency report for submission to the QA pharmacist.
  • 5. Master documentation SOP’s Sample Reports, Lab Specifications. Review and amend all master documentation annually or under direction from the QA pharmacist.

    Destruction of all circulating obsolete copies and superseding of the master copies when required. REGULATORY AFFAIRS 6.

    Namibia Assist the RA pharmacist with regard to all aspects of new product submissions and queries. Assist the RA pharmacist with any correspondence with NMRC and APL India.

    7. Administrative Activities Co-ordination of all stationery orders for the RA department Printer maintenance Samples / courier services (local and international) Co-

    ordination of dossier transfers for off-siting storage CO-ordination of on-site shredding services of confidential documents.

    Matric

    Quality Assurance Diploma

    2 years Pharmaceutical Experience Essential

    Fluent in English & Afrikaans

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