Lead the investigation, resolution, and documentation of customer complaints, ensuring Corrective and Preventive Actions (CAPA) are effectively implemented
Supervise, monitor, and evaluate the performance and achievements of subordinates, providing regular coaching, mentoring, and disciplinary guidance where necessary
Plan and conduct training programs for QA/QC staff, including new employee induction, technical training, and refresher sessions
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Auditing & Compliance: Conduct internal and supplier audits, ensuring adherence to environmental regulations, chain-of-custody certifications (like PEFC or FSC), and safety codes.
Team Leadership: Train, mentor, and lead QC inspectors, graders, and laboratory staff.
Client & Vendor Liaison: Coordinate with suppliers, third-party inspectors, and clients to resolve quality disputes and ensure product specifications are met.
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NPRA & Regulatory Compliance: Lead and coordinate product registration, notifications, and variations with the National Pharmaceutical Regulatory Agency (NPRA / KKM). Prepare, review, and organize complete regulatory dossiers (Dossier submission, Certificate of Free Sale, ingredients validation, etc.).
Stay up to date with Malaysia food and health supplement regulations, ensuring all raw materials, formulations, and labeling meet current NPRA and KKM requirements. Serve as the main point of contact for external regulatory authorities and internal teams on regulatory matters.
Quality Assurance & Quality Control (QA/QC): Oversee daily QC testing (physical, chemical, and microbiological parameters) for raw materials, packaging materials, in-process samples, and finished products. Establish, review, and maintain QA documentation, including Standard Operating Procedures (SOPs), Certificate of Analysis (CoA), Batch Production Records (BPR), and product specifications.
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Lead and coordinate product registration, notifications, and variations with the National Pharmaceutical Regulatory Agency (NPRA / KKM).
Prepare, review, and organize complete regulatory dossiers (Dossier submission, Certificate of Free Sale, ingredients validation, etc.).
Stay up to date with Malaysia food and health supplement regulations, ensuring all raw materials, formulations, and labeling meet current NPRA and KKM requirements.
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Pemeriksaan incoming, in-process dan final inspection
Menjalankan pemeriksaan semasa proses (in-process inspection) dan pemeriksaan akhir (final inspection) pada peringkat pengeluaran yang telah ditetapkan.
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Work closely with local and/or remote Product Development team and follow through all test packages to ensure high quality product release and delivery.
Mentor and coach junior Test Engineers in performing their tasks.
Study and analyze functional specification to develop test cases.
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