· Conduct incoming material inspection, in-process inspection, and final product inspection to verify conformance to specifications.
· Investigate quality non-conformances, defects, and customer complaints; lead root cause analysis (RCA) and corrective and preventive action (CAPA) initiatives.
· Maintain quality records, inspection reports, and traceability documentation in accordance with the company's document control system and Client’s MDR format.
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To ensure complete + correct customer contact data, service data + changes in KN systems while ensuring a best-in-class onboarding + high level of data quality + timeliness including setting up + consistently providing customer reporting.
To consistently perform purchase order + shipment qualification in line with working instructions to ensure full + complete handovers to the OCC, optimizing the customer experience.
To contribute as process owner on continuous improvements of processes + controls for lean processes focusing on cost effectiveness + productivity.
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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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Identification of incorrect coded rules and suggest how to interpret and correctly code the rules.
Ability to work in the fast-paced environment with strict deadlines.
Understanding of pre trade and post trade compliance, implications of various categories of rule types, pre trade and post trade monitoring, generation of reports
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Assist in preparing technical drawing numbering, revision control, and corresponding inspection reports.
Support the maintenance of ISO 9001 documentation: filing, updating QMS records, issuing inspection check sheets, managing non-conformance reports (NCRs) archive.
Provide general administrative support for the QA/QC department: data entry, report generation, assisting audits, etc.
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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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Conduct sensory evaluations and coordinate laboratory testing where required.
Identify, document and promptly escalate non-conforming materials, products or processes. Ensure affected stock is identified and held pending an authorised decision.
Investigate quality issues, support root-cause analysis and follow up on corrective and preventive actions.
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