14 Sep
|
Talent Vision Consulting Services
|
Baddi
14 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.
Solid knowledge of sterility testing, environmental monitoring, microbial testing, endotoxin testing, and aseptic practices.
Valuable understanding of GMP, GLP, SOPs, and pharmacopoeial standards.
Robust 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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