Quality Executive

**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**: ContractContract length: 12 months**Salary**: RM3,500.00 - RM5,000.00 per monthSchedule:- Monday to Friday