Monitor production activities and work closely with the Production Planner to ensure manufacturing schedules are achieved while maintaining quality standards.
Investigate product non-conformities, quality complaints, and production issues; recommend and implement corrective and preventive actions.
Ensure compliance with quality management procedures, work instructions, and customer 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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Analyze measurement results and generate inspection reports; compare actual measurements against Engineering tolerances and GD&T (Geometric Dimensioning & Tolerancing) specifications; identify out-of-tolerance conditions and report discrepancies.
Troubleshoot measurement discrepancies; investigate measurement errors and equipment issues; implement corrective actions to resolve quality problems and prevent defects.
Create and maintain accurate inspection documentation including measurement reports, calibration records, CMM program backups, and inspection logs; organize and archive quality records.
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