Senior Quality Engineer - (Microbiologist & Sterilization)

Job Description Summary

Job Description

Responsible for Lab management - Microbiology, Sterilization, Calibration and associated Quality Engineering Activities

• 1. Oversee the laboratory activities inclusive of microbiology lab activities, sterilization, calibration and chemistry lab activities (if necessary). Manage all laboratory functions and activities associated with all testing analysis.
• 2. Explore and develop new analytical methods or improve current test procedures/technologies.
• 3. Responsible for ensuring that all testing performed at the lab is carried out according to written procedures and properly documented.
• 4. Responsible for the maintenance and operations of Microbiology Lab including supplies and equipment.
• 5. Maintain the housekeeping of all Lab.
• 6. Maintain and update, when necessary, all lab procedures and test methods.
• 7. Responsible for the training of new Microbiology Lab Technicians and retraining of the above.
• 8. Report on regular basis all laboratory issues to superior.
• 9. Responsible for performing sterilization validation/revalidation and autoclave validation/revalidation
• 10. Design investigation program and engineering experiments to determine sources of product nonconformances. Analyze results and recommend action.
• 11. Assist superior in executing special projects or assignments.
• 12. Ensure that all Microbiology Lab Technicians are being trained and that they adhere to instructions in the BOPs.
• 13. Prepare and adhere to annual budget for areas under responsibility.
• 14 Communicate issues relating to Microbiology Lab and Quality issues externally.
• 15. Train Microbiology Lab Technicians on test procedures and “Good Laboratory Practice”.
• 16. QA Representative or Project Leader for associated Design and Non-Design Change Project.
• 17. Perform any other relevant and related responsibilities that may be assigned from time to time as required by the Management.

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