QA Specialist (Pharma / SPC Registered) (Partime) - Part-Time

Position: Healthcare Quality & Regulatory Compliance Specialist (Part time - 25 hour work weeks)

Key Responsibilities:

1. Quality Policies & Procedures: Implement policies to ensure compliance with standards like GDP and GCP.
2. Quality Standards: Write and review SOPs for healthcare-related solutions.
3. Compliance Programs: Implement and support quality programs for local teams.
4. CAPA Management: Lead corrective and preventive actions (CAPAs).
5. Quality Systems: Develop and support eQMS and training programs.
6. Internal Audits: Support internal audits for regulatory readiness.
7. Certification Audits: Lead certification audits with regulatory agencies.
8. Audit Programs: Lead audits to ensure successful outcomes and follow-ups.
9. Customer Liaison: Advise customers on quality requirements and resolve issues.
10. Feedback: Consolidate feedback for Quality Questionnaires and RFQ Proposals.
11. Validation: Lead validation of transportation lanes and critical equipment.

Technical Skills and Experience Required:

1. Hold local pharmacist license (and may be required to hold licenses and permits on behalf of the company)
2. Have at least 1 year relevant experience
3. Have working experience ensuring compliance in accordance with Good Manufacturing Practice (cGMP), Good Clinical Practice (cGCP), Good Distribution Practice (GDP) & ISO 13485 for Medical Devices, IATA CEIV, and other local certifications in a warehouse and transportation business
4. Experience in conducting external and internal audits
5. Must hold at least Bachelor’s degree in Pharmacy

Interested candidates may apply through the application system. We regret to inform only shortlisted candidates will be notified.

EA License No. 01C4394 • RCB No. 200007268E •Derrick Tiew Yong Han EA Registration No. R1877971

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