Responsibilities
- Oversee the document management system, ensuring it adheres to company and regulatory standards.
- Update and distribute documents to the production area, making sure they are the latest versions.
- Manage document changes, including updates, filing, archiving, and retrieval processes.
- Distribute effective documents across the entire site.
- Handle GMP forms, controlling their issuance and ensuring they are reconciled by the respective departments.
- Review and approve GMP documents, checking for compliance with quality standards.
- Align document retention schedules with regulatory requirements and guidelines.
- Administer the Record Management program, which includes cataloging archives, allocating space, and monitoring the archival room.
- Coordinate document destruction with department heads and external contractors.
- Regularly review archived documents for adherence to the retention schedule.
- Provide training on record management and document system usage, including document structure and formatting.
- Support internal audits to verify the effectiveness of internal controls and compliance with document procedures and policies.
- Ensure GMP compliance through regular inspections and process evaluations.
- Assist in maintaining validated states of GMP systems and processes.
Requirement
· Min Bachelor Degree/ Diploma in Science/Engineering or equivalent.
· Min 1 year experience in pharmaceutical industry or related industry.
· Has pior experience in in GMP document control roles preferred.
If you meet the requirements of this role, please email a detailed resume to [email protected].
Alex Goh Hock Leong (Alvin)
(CEI.No: R1763413
Recruit Express Pte Ltd (Healthcare & Life Science)
99C4599
*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.
