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Quality Assurance Coordinator
7 days ago
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:
- Management of documentation (BPR, Protocols etc) i.e., from audit packaging to QA logging.
- Management of query documentation returns from QA/Production/Stores/Support personnel.
- Capturing of all Production info (Stats, data, line dairies etc on relevant programs e.g., PA Performer daily).
- Training of all staff and all training coordinating activities.
- Writing of SOP's.
- Liaise between QA and Production as interface with regards to priority documents for finished product release to ensure supply chain continuity.
- Review and improve current and new documents (BPR, Protocols etc).
- 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.