Qa à Singapour

• 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.

• 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