Document Controller

1. Upkeep Quality System documentation and records in ensuring traceability, integrity, accessibility, in compliance to corporate policies, regulatory and customer requirement.

2. Maintain log sheet, monitor and follow up on Non-conformance Report (NCR), Corrective and Preventive Action (CAPA), Customer Complaint Report (CCR), Change Request Form (CRF), Supplier Corrective Action Request (SCAR), Validation Protocol & Report and Audit Report.

3. Coordinate controlled document revision, distribution and retrieval as per document change control

4. Conduct training for document creation and document control procedure and processes

5. Review document for GDP and ensure compliance.

6. Coordinate the document location distribution audit and procedure yearly review.

7. Assist internal and external quality system audits

8. Copy, scan, filing, archive, backup of documents

9. Prepare and issue Certificate of Conformity (COC)

10. Prepare monthly trend analysis report

11. Maintain retain sample and records.

12. Any other duties as assigned

Job Requirement:

• GCE ‘Ó’ level or higher Diploma in engineering preferred
• Minimum 2 years working experience in maintaining ISO documentation, preferably in medical device manufacturing
• Proficient in English and Chinese translation. "We are seeking candidates proficient in Chinese to effectively communicate with Chinese-speaking clients."
• Writing manufacturing procedures and GMP requirement
• Maintaining quality record
• Effective communication skill and interpersonal skill
• ISO 9001 & ISO 13485 requirements