Job Title: QA Document Officer
Reporting To: QA Supervisor
Job Summary:
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.
4 Training Management
- Organize, archive, and update training plan documents to ensure completeness and compliance.
- Maintain training record databases, track employee training status, and ensure records are accurate and timely.
- Assist in organizing and coordinating internal training activities, supporting training delivery and effectiveness evaluation.
Qualifications:
- College diploma or above, preferably in Pharmacy, Chemistry, or related fields.
- Proficient in Microsoft Office applications.
- Good communication and coordination skills with a strong sense of responsibility.
- Detail-oriented and meticulous.
- Proficient in both written and spoken Chinese and English, to read and writing report in bilingual, and align with stakeholders in China.
- Have knowledge of GMP-related regulations and guidelines
