Responsible for managing, scanning, maintaining, and archiving GMP documents in the factory, ensuring completeness, accuracy, and compliance with GMP and relevant regulatory requirements. Also responsible for managing training materials and maintaining training records. Assist in preparing and supporting documentation for external audits.

Key Responsibilities:

1 Document Management

 Modify formats of quality system documents such as SOPs, TWIs, and record forms.

 Organize regular document reviews and updates to ensure document versions are valid and up-to-date

2 Record Maintenance

 Collect, organize, scan and archive GMP-related records.

 Support internal and external audits by providing necessary documents and records.

3 Document Control System Maintenance

 Maintain and optimize Veeva and TrackWise systems.

 Train relevant personnel on proper use of Veeva and TrackWise systems. ...