Responsibilities:
1. Shop-Floor Quality Oversight
- Provide day-to-day quality oversight of manufacturing operations, including line clearance, in-process checks and real-time GMP compliance monitoring on the production floor.
- Act as the quality point of contact for operational/manufacturing teams on quality-related matters.
2. Deviation & Non-Conformance Management
- Lead and/or oversee investigation of manufacturing-related deviations and non-conformances, ensuring root cause analysis is robust and corrective/preventive actions are effective and timely.
- Review and approve deviation and CAPA records within the manufacturing scope prior to closure.
3. Batch/Production Documentation Review
- Review batch manufacturing records and related production documentation for compliance with GMP and approved procedures prior to release-stage handover.
4. Change Control (Operational Scope)
- Assess and approve change requests affecting manufacturing operations, ensuring appropriate quality risk assessment is performed.
5. GMP/Technical Document Control Oversight
- Provide oversight of the QADC Executive – GMP/Technical's document control activities, ensuring manufacturing-related controlled documents remain current, accurate and audit-ready.
6. Audit & Inspection Support
- Support internal and external audits/inspections relating to manufacturing operations; participate in shop-floor walkthroughs and ensure timely closure of audit findings.
7. Plant Commissioning & Qualification Support
- Provide quality oversight and sign-off support for commissioning, qualification and validation activities ahead of the sterile manufacturing plant's targeted Q************* start-up.
8. Continuous Improvement & Training
- Drive continuous improvement initiatives for operational quality processes and support GMP/quality training for manufacturing personnel.
Pay: RM2,700.00 - RM4,000.00 per month
Benefits:
- Health insurance
- Opportunities for promotion
- Professional development
Work Location: In person