Manage and follow up on deviations, investigations, CAPA, change controls, and quality risk assessments.
Participate in root cause analysis and investigation of quality issues and ensure appropriate corrective and preventive actions are implemented effectively.
Conduct GMP and quality system inspections/audits and support follow-up of audit observations and commitments.
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Define and monitor laboratory KPIs, including testing accuracy, turnaround time, FTQ, and trend performance, ensuring timely reporting and data-driven decision-making.
Manage laboratory resources including budget, consumables, equipment, and calibration programs, ensuring operational efficiency and cost control.
Ensure effective governance of laboratory systems, including:
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Sales Monitoring & Reporting: Monitor sales trends, competitor activities, customer stock levels, and ensure achievement of monthly and yearly sales targets.
Cross-Functional Coordination: Work closely with marketing and internal teams to support promotional activities, payment collection, and smooth customer servicing.
Establish and maintain a reliable supplier network in China to support cost reduction and supply continuity objectives.
Work closely with China suppliers on technical clarifications, tooling, sample submissions, qualification activities, pricing negotiations, and supplier development.
Analyze part costs and identify savings opportunities through localization, alternative materials, design simplification, and manufacturing process improvements.
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Track, update and arrange the regular monthly customer meeting and internal operation meeting.
Ensure the meeting minutes are well documented and properly filed at designated shared location for references. Liaise with procurement personnel to track and update the purchase request, purchase order and budget allocated for Critical Operations.
Does a first level analysis, to ensure all the required information in place before proceeding for approval process.
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