- 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.

📌 Microbiology - Senior Executive/Assistant Manager (Shamirpet)
🏢 Biological E
📍 Shamirpet