Perform routine microbiological analysis of pharmaceutical products, raw materials, purified water and environmental
monitoring samples.
Perform Microbial Limit tests including TAMC and TYMC as per approved procedures and pharmacopoeial requirements.
Conduct environmental monitoring of classified areas, aseptic processing areas, and microbiology laboratories.
Perform viable air monitoring, settle plate monitoring, surface monitoring, and personnel monitoring.
Prepare, sterilize, label, and maintain microbiological culture media as per SOP requirements.
Perform Growth Promotion Testing (GPT) of prepared microbiological media.
Maintain and handle reference cultures and working microbial cultures in accordance with laboratory procedures.
Participated in risk assessment related to environment monitoring program.
Prepare and review existing SOPs periodically to ensure they remain aligned with current procedures, regulatory
requirements, pharmacopoeial standards, and site practices.
Coordinate with QA and relevant departments for SOP review, approval, issuance, revision, and implementation.
Participate in SOP change control and incorporate approved process improvements into controlled documents.
Prepare and review associated SOP formats, forms, checklists, logbooks, protocols, and laboratory records