Microbiology - Deputy Manager / Manager

1 week ago

Hyderabad, India Biological E Full time

Job Description

- Preparation of SOPs ,Protocols i.e One time studies, method validations required for the microbiology laboratory.
- Assessment of Equipment design versus URS/Design qualification.
- Hands on experience on green field projects i.e new laboratory Set-up , AHU, Facility and equipment qualifications.
- Microbiology equipment qualifications and to ensure instruments / equipment's CSV, calibration, performance verification, preventive maintenance checks (PMP) as per the schedule.
- Responsible for review, closure of reports and submission to cross functional departments.
- To ensure the availability of necessary resources (consumables) for smooth and timely execution of the analysis.
- 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.
- To ensure the Good Laboratory Practices (GLP) and Housekeeping activities inside the Laboratory.
- To perform Laboratory Rounds to ensure online compliance.
- Review and Risk assessment preparations of Environmental & Process Monitoring in Grade A, B, C and D areas in Passive Active and Surface Monitoring location selection/ Frequency.
- Execution of the Media fill simulations & Area / Clean room qualifications.
- Review of utility sampling Water analysis and Trend preparation of EMP, Water and Environmental Isolate in clean room.
- Expertise in the testing/validation activities i.e MLT, Sterility, BET, Container closure integrity test, Microbial Limit testing, Water testing, Biological indicator enumeration of paper strips, SS disc, capsules and ampoules.
- Regulatory Audit exposure is mandatory and good presentation, compliance report writing skills

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