Microbiologist, Quality Control

1. To perform sampling and conduct testing of starting materials (APIs and excipients), packaging materials (rubber closures), in-process products, finished products and utilities (water, pure steam and nitrogen) according to sampling instructions and other Quality Control procedures.

2. Responsible for the analysis of samples; water, starting materials, packaging materials, in-process products, finished products, stability samples and testing of miscellaneous samples (eg: for process equipment performance qualification, cleaning validation, media fill, disinfectant) according to approved specifications, test methods and other Quality Control procedures.

3. To provide method validation protocol and report of Microbial Enumeration Test, Bacterial Endotoxin Test and Sterility Test for Pharmaniaga LifeScience products.

4. To perform method validation related to microbiological testing for new products.

5. To conduct viable environmental monitoring of clean rooms, QC sampling area, microbiology laboratory and related laboratory equipment according to procedures.

6. To write and revise/update Standard Operating Procedures (SOP), Specification, Standards Test Procedures (STP), Testing Procedures (TP) and Work Sheet (WS) for Microbiology Laboratory.

7. To conduct the required training such as GMP to laboratory personnel.

8. To monitor changes within the regulatory environment and pharmacopoeia requirement with a view to reporting status of the quality systems to the management team and implement new quality initiatives and strategies.

9. To review and correctly report, advice and action on test result/data; to conduct investigation on any occurrence of test result out of specification as per Quality System.

10. To maintain laboratory record and responsible for safe keeping of all documentations relating to testing eg: preparation of media, culture maintenance, growth promotion test.

11. To purchase the Microbiology Laboratory assets and consumables (CAPEX and OPEX).

12. To assist on the laboratory equipment qualification (IQ/OQ/PQ).

13. To check and organize the calibration and maintenance of laboratory equipment.

14. To ensure records of equipment usage and other activities log sheets are updated and reviewed accordingly.

15. To ensure proper segregation, recording and storage of all wastes related to Microbiology Laboratory.

16. To ensure temperature and relative humidity monitoring in the laboratory and related equipment are conducted as per SOP and record are updated.

17. To monitor changes within the regulatory environment and pharmacopoeia requirement with a view to reporting status of the quality systems to the management team and implement new quality initiatives and strategies.

18. To check and ensure laboratory hygiene and operate to GLP e.g.: cleaning, housekeeping and labeling.

19. To keep adherence to Good Manufacturing Practice (GMP), ISO 9001, ISO 14001, ISO 45001 and ISO 17025.

20. To achieve compliance with HALAL requirements, ISO requirements such as ISO 9001, ISO 14001, ISO 45001, ISO 17025, cGMP and GDP requirements such as PIC/S, US-FDA, EU-GMP, EU-GDP, local regulatory and third-party principal requirement.

21. To undertake any other duties as directed by the immediate supervisor and Management as and when required

Job Type: Full-time

Pay: RM3,000.00 - RM6,000.00 per month

Benefits:

• Dental insurance
• Free parking
• Maternity leave
• Meal allowance
• Opportunities for promotion
• Professional development
• Vision insurance

Schedule:

• Monday to Friday

Supplemental Pay:

• Overtime pay
• Yearly bonus

Education:

• Bachelor's (Preferred)

Experience:

• microbiologist: 2 years (Preferred)
• Manufacturing: 3 years (Preferred)