Company Overview
Our client is a multinational company specializing in the manufacturing of specialty chemicals and bio‑based materials, serving a broad range of industries across Asia‑Pacific, Europe, and North America.
Job Responsibilities
- Lead the implementation, maintenance, internal audit, and management review of ISO 9001 / GMP quality management systems, ensuring deep integration with business operations and continuous improvement.
- Oversee the preparation, review, approval, and control of quality system documents to ensure compliance with ISO, GMP, and FDA requirements, including URS, IQ/OQ/PQ validation, master validation plans, and product stability programs.
- Review and approve deviations, change controls, CAPA, validation plans, and validation reports; organize annual product quality reviews and trend analysis of stability data.
- Organize and lead regular GMP self-inspections, report inspection results to management, ensure timely closure of corrective actions, and promote continuous quality improvement initiatives.
- Guide and coordinate investigations of customer complaints and quality incidents, ensure effective root cause analysis, and implement preventive and corrective actions to maintain product and process reliability.
- Supervise end to end control of key production quality risks, including foreign matter contamination, magnetic material control, and shrinkage prevention systems, ensuring stable and compliant production.
- Lead preparation and coordination for customer audits and regulatory inspections (e.g. GMP and FDA), including audit readiness, cross departmental coordination, and follow up on audit findings.
- Manage Quality Section objectives, task deployment, performance evaluation, training, and team development; ensure compliance with EHS requirements, completion of monthly safety reports, and organization of regular safety meetings.
Job Requirements
- Bachelor's degree or above in Chemistry, Pharmaceutical Science, Life Science or a related discipline.
- Minimum 5 years of quality management experience in the chemical, pharmaceutical, or food industry, exposure in new setup environment would be added advantage.
- Strong knowledge of ISO 9001, GMP, FDA requirements, relevant quality regulations, and common quality management tools.
- Capable in handling quality audits and inspections.
- Excellent leadership, communication and analytical skills.
Interested candidates are welcomed to apply online.
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