Microbiology - Deputy Manager / Manager

Biological E

11 - 15 years

11 - 15 Lacs

hyderabad telangana india

Posted:16 hours ago| Platform: Foundit logo

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Skills Required

sop preparation microbiology testing equipment qualification audit compliance qms

Work Mode

On-site

Job Type

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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