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Supervisor, Quality Control
2 weeks ago
Conduct microbiological tests for raw materials, in process finished products, finished products, and environmental monitoring to ensure conformance with appointed quality standards and specifications from latest pharmacopeia.
- Assist in conducting method validation of microbial testing for finished products and update the test methods according to the current pharmacopeia.
- Assist in updating and completing QC documentation especially in microbiology and GLP related documents.
- Conduct microbiological routine tests on raw materials, in process finished products, and finished products according to the established test protocols and SOPs.
- Conduct environmental monitoring for HVAC AHU in Production Containment and Microbiology Lab areas
- Conduct environmental monitoring for compressed air at the Production containment area
- Sampling and testing Purified Water System at DHAPI plant
- Prepare the media for use in environmental monitoring, microbial testing, and PWS monitoring
- Identify the microbial species isolated from environmental and PWS monitoring.
- Monitor the scheduled waste produced from micro lab and dispose according to schedule waste SOP.
- Assist GLP in liaising with vendor in requesting the quotation for the consumable used in micro lab.
- Assist in keeping up the microbiological laboratory practice and documentation in accordance to the latest GMP and GLP requirements.
- Ensure the inventory of microbiological laboratory is available and sufficient at all times to avoid any delay in microbiological testing.
- Assist in executing Validation and Qualification activities related to microbiological testing as per details in protocols and reporting the results immediately with minimum delay time prior to the project timeline.
- Assist GLP routine such as performing balance performance verification, recording DP, temperature & humidity in Micro lab.
- Assist in Validation Test such as MCT method validation and performance qualification.
- Assist in issuing microbial and GLP reports such as MCT, EM, Balance Performance, Autoclave verification reports.
- Assist in QC documentation such as update SOP, issue incident report, CAPA, and Deviation documentation.
- Report to superior on any deviations from normal quality controls standards.
- Assist in the general maintenance of the laboratory cleanliness and safety in adhering to company's policy.
- Complete other relevant duties and responsibilities assigned by superior.
Requirements:
Experience:
Min Diploma in any Science Discipline
Fresh graduates are welcome. With experience is advantageous.
Familiar with microbiological testing method
Well versed in analytical, problem-solving and communication skills.
Intermediate knowledge of cGMP, GLP and laboratory instruments.
Good Microbiology laboratory skills.
Salary:
RM2, RM3,350.00 per month
Benefits:
- Dental insurance
- Health insurance
- Parental leave
- Vision insurance
Schedule:
- Day shift
Supplemental pay types:
- Yearly bonus
Ability to commute/relocate:
- Glenmarie Industrial Park: Reliably commute or planning to relocate before starting work (required)
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