- A Subject Matter Expect (SME) of Microbiological/ Sterility Assurance tests.
- Lead and conduct method trainings to new lab personnel.
- Initiate and investigate GEMS event via Trackwise system and Laboratory Investigation Report (LIR).
- Participate in cross functional root cause analysis (RCA) during investigation.
- Perform review and approval on QC test results.
- Involve in audit preparation and ready to present during an inspection.
- Lead a Lean Green Belt (LGB) project when tasked.
- Lead a cost saving project when tasked.
- Require to write different types of reports, such as trend report, technical or study report, memo, validation report, investigation report etc.
- Revise Standard Operating Procedures (SOP) and EHS Risk Assessment.
- Perform preventive maintenance for laboratory equipment, such as Temperature Controlled Object (TCO), Biosafety Cabinet (BSC), etc.
- Perform microbiological testing, namely bioburden test, endotoxin test, Growth Promotion Testing (GPT), Biological Indicator (BI) testing, microbial identification (ID), environment monitoring (EM), and plate reading.
- Microbiological sample types include critical utilities, in-process/ Bulk Drug Substances (BDS), raw materials, investigational non-routine samples.
- Perform sterilization cycle using qualified autoclave; perform depyrogenation using qualified cycle.
- Perform aliquoting on Process and Non-Protein samples on a daily basis.
Job requirements: Min. 1-2 years of experience
Interested candidates, do submit your resume to [Click Here to Email Your Resume]
Jocelyn Chan| Consultant | Recruit Express Pte Ltd (Healthcare & Lifescience)
Company EA Licence number : 99C4599
Personnel EA License: R1331820
Recruit Express Pte Ltd