Roles & Responsibilities
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 studiesExperience in quality assurance - compliance in pharmaceutical industry will be highly preferredAll 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
Tell employers what skills you have
Document Management
Pharmaceutical Industry
CAPA
Pharmaceutical Manufacturing
Quality Management
Quality Assurance
Healthcare
ISO
GMP
Chemistry
Compliance
Project Management
Audits
Pharmaceutical industry experience
Regulatory Requirements
Cataloging
Manufacturing
Chemical Engineering