Documentation and Records Controller (QA)

Documentation and Records Controller (QA)

The Quality Associate – Documentation and Records Management is responsible for managing all GMP related documents and records in a secure and timely manner. This position supports Quality and Production team functions and compliance activities in alignment with TGA regulations, PIC/S GMP guidelines, and company SOPs.

Key Responsibilities:

• Responsible for the management of all GMP documentation in line with PIC/S Guide to GMP requirements including the following:
• Maintenance of all Master GMP documents including but not limited to SOPs, forms, specifications, batch production records etc. in both paper and electronic forms on site and ensure they are up to date.
• Archiving of superseded documents.
• Retention and destruction of documents in line with regulatory requirements and according to SPA procedures.
• Providing access to documents on request.
• Scanning and...