Responsibilities
- Maintain and manage the site’s document management system, ensuring compliance with company quality standards, ICH guidelines, and regulatory requirements.
- Update and control all documentation, including filing, archival, retrieval, and distribution of effective documents across the site.
- Oversee issuance and reconciliation of critical GMP forms and ensure adherence to cGMP and regulatory standards.
- Review and approve GMP documents to ensure accuracy and compliance.
- Align document retention schedules with company and regulatory requirements.
- Manage the record management program — cataloging, archival space allocation, labeling, and monitoring archival storage.
- Coordinate the secure destruction of documents with department owners and third-party vendors.
- Conduct periodic reviews of archived documents and ensure timely disposal based on retention schedules.
- Provide training on document management systems, hierarchy, structure, and formatting requirements.
- Prepare deviation reports and ensure effective implementation of corrective and preventive actions.
- Manage and validate document control and archival change processes.
- Support internal audits and maintain alignment with document control and retention policies.
- Ensure inspection readiness and support audits from regulatory agencies and customers.
- Participate in GMP walkdowns to verify compliance with procedures and standards.
- Support the maintenance of validated GMP systems and processes.
- Perform any other duties as assigned by the supervisor.
Requirements
- Degree in Chemistry/ Lifescience/ Chemical Engineering/ or any related course of studies
- Experience in quality assurance - compliance in pharmaceutical industry will be highly preferred
All qualified applicants, please send in your resume to:
triciagoh@recruitexpress.com.sg
Tricia Celestine Goh (R1981653)
Recruit Express Pte Ltd | Company Reg. No. 199601303W | EA License Number: 99C4599