Day-to-Day Responsibilities
Test raw materials, in-process samples and finished medicines for bacteria, fungi and endotoxins using pharmacopoeia methods.
Carry out sterility tests and bioburden counts on products and on sterile manufacturing areas.
Monitor cleanrooms, air, water and surfaces through environmental monitoring, and act quickly when results go outside limits.
Prepare culture media, reagents and controls, and keep lab equipment such as incubators, autoclaves and biosafety cabinets working properly.
Record every result in logbooks or a laboratory information system (LIMS), and help investigate out-of-specification (OOS) results and deviations.
Support validation of sterilisation cycles and media fill studies with production and quality assurance (QA) teams.
Follow GMP, Good Laboratory Practice (GLP) and data integrity norms, and prepare the lab for regulatory and customer audits.
Train production staff on aseptic behaviour, gowning and hygiene.


