Key Responsibilities:
- To perform quality control microbiological testing of raw materials, incoming goods, intermediates, in-process, drug substance, and/or finished products under cGMP conditions for QC release or part of stability studies
- To perform monitoring and testing for the facility and utilities system
- To support instrument qualification
- To support equipment qualification e.g., controlled temperature units, isolator, biosafety cabinets
- To perform and coordinate calibration, preventative maintenance and repairs or laboratory instruments/equipment
- To support aseptic process simulations
- To support microbiological method transfer/development/validation/verification/suitability
- To perform periodic review for laboratory documents
- To manage microbiological inventory required for sampling and testing
- To ensure adherence to ALCOA principles for managing laboratory data
- To adhere to site/job role training plan, and maintain individual training records
- To support continuous improvement initiatives
- To maintain laboratory housekeeping using 5S approach
- Ensure timely escalation of investigations accidents, near misses and breaches of policies
- To carry out tasks required by the reporting Manager
Qualifications:
- Bachelor’s degree or higher in biological sciences, biotechnology, pharmaceutical sciences or equivalent with min 3-5 years of working experience
- Prior experience in working in a GMP laboratory preferred
- In-depth knowledge of cGMP compliance principles and a strong quality-focused mindset.
To apply for this job please visit en-sg.whatjobs.com.
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