Quality Executive
1 month ago
**Responsibilities**:
- Ensure maintenance and updating of Instrument Calibration Record Sheets, Standard Gas Certificates, and Sensor/Cell/Probe Calibration Certificates.
- Review batch records encompassing production, non-conformance, starting materials, analysis results, calibration, maintenance, and other relevant records affecting product quality.
- Guarantee correct storage, handling, and distribution of finished products, maintaining gas quality and containment package condition throughout the product life-cycle.
- Review inspection/testing records for starting materials, packaging, labeling, intermediate products, and finished product batches.
- Verify adherence to approved process & product specifications, sampling instructions, test methods, and site quality control procedures.
- Implement and maintain the Quality Management System for medical gas manufacture, ensuring safety for intended use at the site level.
- Evaluate finished product batch records to ensure compliance with procedures, directives, Marketing Authorizations, and Linde Healthcare Minimum Requirements.
- Investigate and take corrective/preventive actions for product non-conformances and internal CARs, approving non-conformance report closure.
- Compile site quality data and trending analysis, providing input to the Pharmacist for Product Quality Review.
- Collaborate with the Pharmacist and Central Quality team for mock recall exercises.
- Lead internal and external audits (e.g., GMP or healthcare-related) for medical filling sites, ensuring regular self-inspections for system effectiveness and addressing non-conformances.
- Provide support and feedback to the Pharmacist in reviewing product specifications, sampling instructions, test methods, and other Quality-related procedures.
- Assist the site team in validating analytical and manufacturing processes and systems with regional QRA, Technical, Procurement, SHEQ, and relevant teams.
- Verify completion of initial and continuing training for personnel with GxP responsibilities and ensure appropriate GMP-related training for their roles.
- Maintain good hygiene and cleanliness practices.
**Qualification**:
- Minimum diploma holder with 2 years of experience in medical gas or pharmaceutical industry manufacturing and/or quality control.
**Job Type**: Contract
Contract length: 12 months
**Salary**: RM3,500.00 - RM5,000.00 per month
Schedule:
- Monday to Friday
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