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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