Quality Control Executive

2 weeks ago


Kuching, Sarawak, Malaysia Kingfisher HR Solutions Group Full time

Responsibilities:

  • Ensure maintenance and updating of Instrument Calibration Record Sheets, Standard Gas Certificates, and Sensor/Cell/Probe Calibration Certificates.
  • Review batch records encompassing production, nonconformance, 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 lifecycle.
  • 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 nonconformances and internal CARs, approving nonconformance 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 healthcarerelated) for medical filling sites, ensuring regular selfinspections for system effectiveness and addressing nonconformances.
  • Provide support and feedback to the Pharmacist in reviewing product specifications, sampling instructions, test methods, and other Qualityrelated 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 GMPrelated 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, RM5,000.00 per month

Schedule:

  • Monday to Friday

Ability to Commute:

  • Kuching (required)

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