Quality Assurance & Regulatory Affairs Specialist (Pharma Industry & GDP)
PERSOL Malaysia- Posted 13 hours ago
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Job Description
Position: Quality Assurance & Regulatory Affairs Specialist
Location: 1 Powerhouse, Persiaran Bandar Utama, Petaling Jaya, Selangor
Industry: Biotechnology, biopharmaceutical, and pharmaceutical
Employment Type: 6 months contract via PERSOL (maternity replacement)
Working Hours: Monday – Friday | 9:00 AM – 6:00 PM
Working Arrangement: Hybrid (3 Days WFH, 2 Days WFO)
Salary: RM7,000 – RM11,000 (based on experience & skills)
Key Responsibilities
Quality Assurance & GDP Compliance
- Support implementation and maintenance of GDP processes across distribution activities
- Coordinate distributor, logistics service provider, and third-party qualification activities
- Support audits, due diligence assessments, CAPA tracking, and follow-up activities
- Maintain quality agreements and coordinate periodic reviews
- Support transport qualification documentation and compliance activities
Quality Management System (QMS)
- Track deviations, product complaints, temperature excursions, and quality events
- Monitor CAPA implementation and follow-up actions
- Maintain quality documentation, records, reports, and performance metrics
- Support document control, SOP reviews, work instructions, and procedure updates
- Coordinate GDP training and maintain training records
Regulatory & Operational Compliance
- Ensure compliance with Malaysian pharmaceutical regulations and internal quality procedures
- Liaise with local stakeholders on quality and regulatory matters
- Maintain licenses, permits, and quality documentation required for local operations
- Support regulatory activities, new product introductions (NPI), and product quality compliance
- Coordinate documentation related to labeling, stickering, and record-retention requirements
Audit & Inspection Readiness
- Support preparation for NPRA and other regulatory inspections
- Maintain inspection readiness documentation and records
- Coordinate responses to audit findings and information requests
- Support readiness reviews, mock inspections, and compliance initiatives
What We're Looking For
- Bachelor's Degree in: Pharmacy (Preferred), Life Sciences, Chemistry, Biotechnology, Pharmaceutical Sciences or Related Scientific Disciplines
- 5-7 years of experience in Regulatory Affairs and/or Quality Assurance within the pharmaceutical industry
- Experience supporting pharmaceutical quality systems and compliance activities
- Knowledge of GDP, GMP, CAPA, deviations, document control, and training systems
- Experience supporting audits, inspections, distributor oversight, or third-party qualification activities
- Exposure to health authorities, regulatory requirements, and pharmaceutical compliance programs
- Experience supporting manufacturing, supply chain, or distribution quality operations
Bachelors/ Degree
More Info
About Company
With deep roots across 13 APAC markets, PERSOL delivers strategic workforce solutions that blend local expertise with regional scale.
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For more information, please visit www.persolmalaysia.com
About Recruiter
Ramyia Ashwini Arunaselam