Job Description Summary

To carry out all range of microbiological analysis, maintaining all laboratory equipment, chemicals and glassware as required under Good Laboratory Practice (GLP) and sterilization related activities.
Responsible for the execution of all microbiological tests required, request maintenance and calibration of laboratory and equipment and sterilization related activities.
Assist Microbiologist/Quality Engineer in validation activities.
Monitor and manage lab inventory and maintenance.

Job Description

ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. Responsible for all Microbiology Lab testing and conduct them according to GLP.
2. Responsible for proper documentation and recording of all test results.
3. Responsible for stocking and ordering of laboratory chemicals, media and other supplies.
4. Responsible for monitoring all results produced by Microbiology Lab.
6. Responsible for preparing trend micro lab testing data
5. Specific laboratory testing:
a) Sterility test
b) Maintenance of stock culture
c) Environmental monitoring on air and work surface and water analysis
d) Product bioburden
e) Microorganism identification
f) Bacteriostasis and fungistasis
g) Bioburden recovery test

6. To assist Microbiologist/ Senior Quality Engineer in dummy/PCD preparation during EO
and Gamma sterilization validation.
7. Responsible in performing Gamma Dose Audit testing.
8. Responsible in performing annual autoclave revalidation.
9. Responsible for maintenance of lab equipments.
10. To assist Microbiologist in starting up new test methods and in writing test methods.
11. Ensure good housekeeping and 5S practice in Microbiology Lab.
12. To assist Microbiologist/ Senior Quality Engineer in OOS investigation of testing failures
13. Responsible in preparing sterilization certification release
14. Responsible in preparing Quarantine shipment product - Exhibit A and verifying
Quarantine Certificate - Exhibit B and Quarantine product release - Exhibit C for
shipment.
15. Responsible for preparation of SOP’s, limit calculation, validation protocols, preparation
and execution of process validation/qualification.

16. Carry out any other related tasks assigned by Microbiologist/ Quality Engineer.

17. Ensure adherence to Environmental, Safety and Health policies.

18. Carry out project as directed by superior.

Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)

Additional Locations

Work Shift

MY3 Normal 8a-4p Group 16 (Malaysia)