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OVERVIEW
- Assist QA-Manager to handle customer complaints and shipment failures in a timely manner and to maintain complaint files (external and internal) as per quality standard, customers, and regulatory requirements.
DUTIES AND RESPONSIBILITIES
- Facilitate and monitor customer complaints investigation by complaint handling procedure.
- Ensure customer complaint/feedback received is logged and investigation being conducted timely.
- Plan and lead the internal discussion with respective process owners on the customer complaint/ feedback received.
- Issuance of Corrective Action/ Preventive Action (CAPA) request and ensure close follow-up with process owners for the complete CAPA submission within the lead time set.
- Prepare the report/response letter for QA-Manager and QA- Senior Manager / Deputy General Manager’s review and approval; and submission of the approved report to Sales / Customer within the required lead-time.
- Ensure complaint log and relevant documentation is maintained and updated.
- Facilitate and monitor shipment failures investigation through CAPA system.
- Ensure shipment failures received are logged and investigation being conducted timely.
- Plan and lead the internal discussion with respective process owners on the shipment failures received.
- Issuance of Corrective Action/ Preventive Action (CAPA) request and ensure close follow-up with process owners for the complete CAPA submission within the lead time set.
- Ensure shipment failure log and relevant documentation are maintained and updated.
- Manage and monitor Corrective and Preventive actions concerning the CAPA Procedure.
- Ensure that the CAPA issued are being followed-up and all actions taken is completed within the promised dateline
- Verify the completeness and the effectiveness of the corrective actions within the timeframe with proper evidence keeping.
- Ensure CAPA and all supporting documents are maintained.
- Drive analysis of complaint and shipment failures data for improvement
- Ensure customer complaint/ feedback and shipment failure information is properly logged and accurately categorized for analysis.
- Utilize QC tools e.g. Pareto analysis, trend chart in identifying target area for improvement.
- Compile and present analysis for management review in driving improvement actions.
- Assist QA- Manager in reviewing and updating complaint handling procedures to ensure its accuracy, suitability and effectiveness.
- Escalate all unresolved issues to Manager for further action, whist keeping process owner informed.
- Ensure proper updating and up keeping of department required quality records.
- Assist in undertaking and managing regulatory, customer, internal and external audits.
REQUIREMENT
- Minimum Bachelor's Degree in Science.
- Excellent communication and written skills in both English and Bahasa Malaysia.
- At least 2-3 years of working experience in the related field is required for this position.
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