The posting
Job Description:
• Conducting daily microbial and bioassay testing for raw materials, in-process, finished products, stability studies and other related testing.
• To ensure testing are completed on time and be able to provide accurate and timely results on a consistent basis.
• To conduct laboratory investigation upon Lab errors and OOS (out of specs) when required.
• To develop, draft and review SOP (standard operating procedure) for microbiology testing.
• Maintaining the usage and compliance of Reference Organisms.
• Collect samples and perform test for Environment monitoring, Air monitoring and Water testing for Production Controlled Area.
• Collect samples and perform testing for Process Validation (PV) and Cleaning Validation (CV).
• Assist in complaint investigation testing when required.
• To co-ordinate with outsourced laboratories for testing when required.
• Maintain Sanitation and Sterilization of Microbiology Laboratory.
• Ensure and maintain neatness, cleanliness and safety of the Microbiology Laboratory in accordance with cGMP and GLP.
• Preparation of test solutions and standardizations of volumetric solution under reference standards
• Perform Microbial Assay (Antibiotics), Media received & Growth Promotion Test for the Media used for testing.
• Manage Microbiology Laboratory equipment calibration & maintenance.
• Trending and maintaining the reports for Purified Water testing & Environment Monitoring.
• Training of analyst/intern to work in Microbiology Laboratory.
• Any other duties as assigned by superior.
Requirements:
* Diploma/Degree in Microbiology or related study.
* 1-2 years’ experience in a pharmaceuticals microbiology preferred
* Must be able to work independently



