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 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.