Document Controller

Forefront Medical Investment Pte Ltd; Singapore; On-site; SGD 45,000 - 67,000; Full time

Job summary

Forefront Medical Investment Pte Ltd in Singapore seeks a QA Documentation Specialist to maintain ISO documentation, records and GDP compliance across the quality system. You will coordinate document revision, support audits, prepare Certificates of Conformity, and maintain quality records in a fast-paced medical device environment.

Fluent English and Chinese translation skills are required to communicate with Chinese-speaking clients, suppliers and partners.

Qualifications

• GCE O 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.
• Writing manufacturing procedures and GMP requirements.
• Maintaining quality records.
• Effective communication and interpersonal skills.
• ISO 9001 & ISO 13485 requirements.

Responsibilities

• Maintain ISO documentation and records to ensure traceability and compliance.
• Monitor NCR, CAPA, CCR, CRF, SCAR, validation protocols and audit reports.
• Coordinate controlled document revision, distribution and retrieval.
• Conduct training on document creation and control procedures.
• Review documents for GDP compliance.
• Coordinate annual document location audits and reviews.
• Assist internal and external quality system audits.
• Copy, scan, filing, archive, and backup of documents.
• Prepare and issue Certificates of Conformity.
• Prepare monthly trend analysis reports.
• Maintain retained samples and records.
• Perform other duties as assigned.

Skills

English translation

Chinese translation

Effective communication

Interpersonal skills

Education

GCE O level or higher Diploma in engineering

Job description

Job Description:

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 inChineseto effectively communicate withChinese-speaking clients."

• Writing manufacturing procedures and GMP requirement

• Maintaining quality record

• Effective communication skill and interpersonal skill

• ISO 9001 & ISO 13485 requirements