Senior Scientist - QC Microbiology

Job 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
• Environmental Monitoring

Requirements:

Bachelor Degree in Microbiology, Biology, Biotechnology, Life Sciences or equivalent.

2-3 years of experience in the pharmaceutical or medical devices industry, with experience on working in a laboratory environment preferred, but fresh graduates with laboratory experience during tertiary studies is acceptable.