全职 Compliance Executive – Audits - Supplier-Vendor Qualification 工作, 薪水 up to MYR 4,000, Kenanga Network Selangor 公司招聘中 - Ricebowl

QUALIFICATIONS:

• Bachelor’s Degree in Pharmacy, Life Sciences, Engineering or a related discipline; a Lead Auditor certification (e.g. ISO 9001/13485, GMP) is an added advantage.

EXPERIENCES:

• Minimum 3 - 4 years of experience in Quality Assurance, with a focus on internal/external audits and supplier/vendor qualification, within a GMP-regulated (pharmaceutical or medical device) environment.

CHARACTERISTICS:

• Strong analytical and investigative skills; assertive with good negotiation and influencing skills; high level of integrity and objectivity; excellent communication and report-writing skills; able to manage multiple audits/qualifications concurrently and work independently.

JOB PURPOSE:

• To lead and manage the Company's internal audit programme and supplier/vendor qualification processes across both manufacturing and non-manufacturing scope, ensuring compliance with applicable GMP, regulatory and quality requirements, and that suppliers/vendors are appropriately qualified and monitored, thereby supporting the organization's audit-readiness, supply chain quality assurance and continuous compliance.

RESPONSIBILITIES:

1. Internal Audit Programme Management

• Plan, schedule and execute the internal audit/self-inspection programme across QA, manufacturing and non-manufacturing functions, in accordance with the Company's audit procedure and applicable regulatory requirements.
• Prepare audit reports, track findings to closure, and escalate significant compliance risks to management.

2. External Audit & Inspection Support

• Coordinate and support the Company's readiness for external audits/regulatory inspections, acting as a key point of contact during inspections.
• Track and ensure timely closure of external audit/inspection findings and commitments.

3. Supplier/Vendor Qualification

• Manage the supplier/vendor qualification programme, including initial qualification, periodic requalification and risk-based supplier audits for materials, components and outsourced services relevant to both manufacturing and non-manufacturing product lines.
• Maintain the approved supplier/vendor list and associated qualification records.

4. Supplier Quality Monitoring

• Monitor ongoing supplier/vendor performance (e.g. quality agreements, complaints, non-conformances) and initiate corrective actions or requalification where necessary.

5. Compliance Risk Management

• Identify, assess and track compliance risks across audit and supplier qualification activities; support risk mitigation planning.

6. Documentation & Reporting

• Maintain audit schedules, supplier qualification files and compliance metrics/reports; present audit and supplier qualification status to the Head of QA/management as required.

7. Cross-functional Collaboration

• Work closely with the QMS Executive, Operational Quality Executive, Procurement and other relevant departments to align audit and supplier qualification activities with the QMS and business needs.

8. Plant Commissioning Support

• Support audit and supplier qualification readiness for commissioning, including qualification of new suppliers/vendors specific to the plant.

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:

• Quality Assurance, with a focus on internal/external audits : 3 years (Required)

Work Location: In person