Scientist II - QC Microbiology

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

Education background:

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

Experience:

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.