Quality System Regulatory Compliance Specialist Pharma MNC/ West
2 days ago
The Opportunity:
- Focus: Ensures site compliance with GMP and regulatory requirements by managing quality systems, supporting audits and inspections, and driving continuous improvement in training, CAPAs, and performance metrics.
- Office location: West
- Working hours: 5 days a week (Mon-Fri), 9am - 6pm
- This role will start off as a 6-months contractual assignment.
Role Summary
This role supports the site's Quality System and ensures ongoing compliance with GMP and regulatory requirements. Key duties include managing the internal audit (self-inspection) program, assisting with audit and inspection readiness, and supporting the implementation of core Quality Systems such as deviations, CAPAs, change control, training, and KPIs. The position also helps maintain Quality Plan activities, oversees user access to Quality Systems, and contributes to improving training processes.
Key Responsibilities
- Coordinate the self-inspection program, including plans, reports, and follow-up actions.
- Assist in preparing for audits and regulatory inspections through document coordination and area walkdowns.
- Support quality system processes and compliance activities.
- Compile KPI data for monthly reviews and management reporting.
- Maintain Quality System access and provide administrative support for training documentation.
- Bachelor's degree in Pharmacy or Life Sciences preferred.
- 5+ years in a GxP environment, with at least 1 year in QA.
- Strong communication skills and fluency in English.
- Experience with quality systems, audits, and documentation, plus strong analytical skills.
- Send your updated cv at
- Email Subject: Quality System Regulatory Compliance (QSRC) Specialist [Pharma MNC/ West]
- Only shortlisted candidates will be contacted
Lim Jia Yi
EA License Number: 91C2918
Personnel Registration Number: R
Lim Jia Yi
EA License No: 91C2918
Personnel Registration Number: R
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