Microbiology - Senior Executive/Assistant Manager
Biological E Ltd. · Not specified · onsite · Posted 59d ago
Undisclosed7–10 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- 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 Good 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.
Sourced from naukri
Skills
InjectablesMicrobiologyReviewer
About Biological E
Biological E Ltd.
Pharma
3.4k+
employees
1953
73 years old
Hyderabad/Secunderabad, Telangana
India
₹6.4L PA avg
Avg at Biological E
About
Leading Indian biopharma firm supplying vaccines to 130+ countries, known for producing over 2 billion COVID-19 doses and advancing global immunization efforts.
Industries
Pharma
Employee ratings
10 reviews
4.2/ 5
Culture
3.7
Career growth
3.6
Work-life
3.6
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