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* Archiving of superseded documents.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 uploading digital versions of physical documents.
* Creating and editing document templates.
* Control of other commercially sensitive documentation.
* Provide relevant training to other personnel when needed.
* Other duties as agreed.
Key Relationships:
* Quality Assurance and Quality Control personnel
* Manufacturing and Packaging Operations personnel
* Warehouse and Supply Chain personnel
Qualifications & Experience:
* Bachelor's degree in Microbiology, Chemistry or Biotechnology, Chemical Engineering or related fields.
* Minimum 2 years' experience in a GMP-regulated facility.
* Knowledge of PIC/S Guide to GMP, documentation management systems, TGA regulations, and Australian regulatory environment for complementary medicines.
* Demonstrated ability to write and review technical documents.
* Strong understanding of GMP quality systems.
* Experience in a complementary medicine or probiotic manufacturing facility.
* Experience with Google Docs software system
* High attention to detail and documentation accuracy.
* Strong analytical and problem-solving skills.
* Effective written and verbal communication.
* Ability to manage multiple projects and priorities.
* Collaborative team player with a proactive mindset.
Performance Measures:
* Compliance with internal SOPs and regulatory requirements.
* Timely completion, issuance and archiving of documents.
* Audit readiness and minimal audit findings.
This role is primarily site-based, operating within GMP manufacturing and office environments. Occasional extended hours may be required.
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