Executive, Quality Assurance (Document Controller)

QUALIFICATIONS:

• Bachelor’s Degree in Pharmacy, Life Sciences, Science, Engineering or a related discipline.

EXPERIENCES:

• Minimum 2-3 years’ working experience in Quality Assurance / Document Control, preferably within a GMP-regulated (pharmaceutical or medical device) environment.

CHARACTERISTICS:

• Meticulous and detail-oriented with strong organizational and time-management skills; high level of integrity and confidentiality in handling-controlled documents; good communication and interpersonal skills; able to work independently, multi-task and meet deadlines under minimal supervision.

JOB PURPOSE:

• To manage and maintain the Company's Quality Management System (QMS) documentation and document control processes, ensuring all controlled documents (SOPs, Work Instructions, Policies, Forms, specifications and records) are created, reviewed, approved, issued, distributed, retrieved and archived in accordance with Good Manufacturing Practice (GMP) / Good Documentation Practice (GDP) and applicable regulatory requirements, thereby supporting the organization's compliance, audit-readiness and continuous improvement of the QMS.

RESPONSIBILITIES:

1. Document Control & Lifecycle Management

• Administer the full lifecycle (drafting support, formatting, numbering, review/approval routing, issuance, distribution, retrieval and archival) of controlled documents (SOPs, Work Instructions, Policies, Forms, specifications) across the Company's applicable product lines and functions.
• Maintain the master document list/register, ensuring all controlled documents are current, accurate and accessible to authorized users.

2. Change Control Administration

• Process and track change requests for controlled documents, ensuring changes are reviewed, approved and implemented within defined timelines.
• Follow up with document owners/approvers to prevent overdue change control items.

3. QMS Records & Quality Events Support

• Log, track and maintain records for deviations, CAPAs and non-conformances, ensuring traceability and timely closure.
• Support QA/QMS management in compiling quality metrics and reports.

4. Periodic Review & Document Retention

• Track and ensure timely periodic review/revalidation of controlled documents in accordance with the Company's document control procedure.
• Ensure obsolete documents are withdrawn and retained records are archived per the Company's retention policy.

5. Training Record Coordination

• Coordinate and maintain training records related to controlled documents, ensuring relevant personnel are trained on current document versions prior to effective dates.

6. Audit & Inspection Readiness

• Respond promptly and accurately to internal and external audit/inspection requests for controlled documents.
• Maintain document files in an audit-ready state at all times.

7. Compliance & Continuous Improvement

• Keep abreast of applicable regulatory requirements (e.g. GMP, GDP, ISO 13485/MDR, ISO 9001) affecting document control practices.
• Identify and support continuous improvement initiatives for document control processes and systems.

Pay: RM2,700.00 - RM4,000.00 per month

Benefits:

• Additional leave
• Dental insurance
• Flexible schedule
• Free parking
• Health insurance
• Maternity leave
• Meal allowance
• Opportunities for promotion
• Professional development
• Vision insurance

Ability to commute/relocate:

• Rawang: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• in Quality Assurance / Document Control: 2 years (Required)

Work Location: In person