Experience in review of laboratory reports, environmental monitoring, Water and isolate identification trends.
Responsible to review the documents of BIs, Bioburden, CCIT, Sterility, BET, water analysis, Preservative efficacy test and Microbial Limit Test.
To initiate and participate in QMS activities like OOL, Change control, CAPA and Deviations.
To co-ordinate with cross functional teams for closure of QMS activities.
Hands on experience in the equipment qualifications and closure of its relevant documents.
Responsible for preparation and review of microbiology investigations and their timely closure.
To ensure adherence of instruments / equipments calibration/ performance verification/preventive maintenance checks (PMP) as per the schedule.
To ensure the Positive Laboratory Practices (GLP)
and housekeeping activities inside the Laboratory.
Experience in Preparation of laboratory investigation reports.
Experience in preparation of quality risk assessments.
Experience in preparation of SOP’s, protocols, reports
Experience in review of microbiology-related GMP documents including Standard Operating Procedures (SOPs), protocols, reports, specifications, worksheets, validation documents, trend reports, logbooks, and laboratory records
Ability to maintain operational and GMP readiness of the Microbiology laboratory
Exposure to the regulatory inspections i.e US FDA, MHRA and TGA.