11 Sep
|
Talent Vision Consulting Services
|
Baddi
11 Sep
Talent Vision Consulting Services
Baddi
– Assistant Manager – Microbiology
Position: Assistant Manager – Microbiology
Experience: 10–12 Years
Industry: Pharmaceutical
Plant Experience: Mandatory experience in an Injectable Plant
Location: Baddi, Himachal Pradesh
Key Responsibilities
- Manage and supervise the Microbiology Quality Control activities at the injectable manufacturing plant.
- Ensure microbiological testing of raw materials, packaging materials, finished products, water, and environmental monitoring samples.
- Handle environmental monitoring of clean rooms, sterile areas, and manufacturing areas as per applicable procedures.
- Perform and review Microbial Limit Tests, sterility testing, bacterial endotoxin testing, bioburden testing, and other microbiological analysis as applicable.
- Ensure compliance with GMP, GLP, SOPs, pharmacopoeial requirements, and regulatory guidelines.
- Review microbiology test results, analytical data, worksheets, logbooks, and related documentation.
- Handle OOS/OOT investigations, deviations, CAPA, change controls, and laboratory investigations related to microbiology.
- Ensure proper maintenance, calibration, qualification, and validation of microbiology laboratory equipment.
- Supervise and guide microbiology team members and ensure timely completion of testing activities.
- Ensure proper handling, identification, storage, and disposal of microbial cultures and laboratory samples.
- Participate in internal, customer, and regulatory audits and support the preparation of audit-related documentation.
- Ensure compliance with data integrity and documentation practices within the microbiology laboratory.
- Coordinate with QA, Production, Engineering, and other relevant departments for microbiology-related activities.
- Maintain laboratory housekeeping, safety, and contamination-control practices.
Candidate Requirements
- M.Sc./B.Sc. in Microbiology or a relevant discipline.
- 10–12 years of relevant experience in the pharmaceutical industry.
- Mandatory injectable/sterile manufacturing plant experience.
- Strong knowledge of sterility testing, environmental monitoring, microbial testing, endotoxin testing, and aseptic practices.
- Good understanding of GMP, GLP, SOPs, and pharmacopoeial standards.
- Strong documentation, team-handling, problem-solving, and communication skills.
Pay: ₹40,000.00 - ₹55,000.00 per month
Perks
- Paid sick time
- Provident Fund
Work Location: In person
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