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Quality Assurance Coordinator

7 days ago

Durban, KwaZulu-Natal, South Africa Cipla Africa Full time

The successful candidate will have a strong background in document management and review, with a focus on cGMP compliance. Key responsibilities will include:

Key Responsibilities:
  • Responsible for ensuring the 'real time' completion of Batch Packaging Records (BPR), Log Sheets, SAP Transaction etc during all production processes.
  • BPR's are reviewed and made current where necessary.

Additional responsibilities will include:

  1. Management of documentation (BPR, Protocols etc) i.e., from audit packaging to QA logging.
  2. Management of query documentation returns from QA/Production/Stores/Support personnel.
  3. Capturing of all Production info (Stats, data, line dairies etc on relevant programs e.g., PA Performer daily).
  4. Training of all staff and all training coordinating activities.
  5. Writing of SOP's.
  6. Liaise between QA and Production as interface with regards to priority documents for finished product release to ensure supply chain continuity.
  7. Review and improve current and new documents (BPR, Protocols etc).
  8. Assist in drawing up of documents (BPR and Protocols).

You will interact with various departments, including Procurement, Packaging, Planning, Environment and Safety, Quality Control and Quality Assurance, and Vendors.

Requirements:
  • Matric/grade 12.
  • Pharmacist Assistant (Basic/post basic) will be advantageous.
  • Computer Literacy.
  • 2 years in a pharmaceutical manufacturing environment.
  • 1 year administration in pharmaceutical environment.