Key Responsibilities
Perform routine Environmental Monitoring (EM) activities in classified cleanrooms (Grade A, B, C, D areas).
Conduct viable and non-viable monitoring including- Active air sampling, Surface monitoring (contact plates/swabs), Personnel monitoring, Settling plate exposure studies, Particle monitoring support
Perform microbiological testing of Raw Materials, Water Systems (PW/WFI), In-process samples, and Finished Products as per validated methods.
Handling sterility testing activities and ensure proper aseptic handling practices in microbiology laboratory.
Perform microbial limit tests, endotoxin testing support (where applicable), and bioburden testing.
Prepare and review EM and microbiology test records, worksheets, and logbooks in compliance with GMP.
Perform the investigation of EM excursions & Microbiology testing, OOS, OOT, and deviations, and support root cause analysis.
Ensure proper incubation, observation, and interpretation of microbiological test samples.
Maintain microbiology laboratory hygiene, aseptic practices, and contamination control standards.
Ensure calibration, cleaning, and maintenance of microbiology instruments and EM equipment.
Involve in change control review and approval, Deviation, Investigation and root cause investigation. Involve in SOP Review and its implementation and Training.
Support media fill (APS) activities from microbiological monitoring perspective.
Maintain compliance with ALCOA+ data integrity principles in manual and electronic documentation systems.
Ensure timely completion of testing activities to support production and product release timelines.
Assist in preparation and revision of SOPs, protocols, and microbiology-related documentation.
Coordinate with QA, Production, Validation, and Engineering teams for microbiological compliance activities.
Participate in regulatory and customer audits by providing required microbiological data and records.
Support implementation of contamination control practices in sterile manufacturing areas.
Eligibility
M.Sc. (Microbiology / Biotechnology / Life Sciences) or equivalent qualification with Minimum 7–10 years of relevant experience in QC Microbiology.
Experience in sterile injectable manufacturing environment is mandatory/ preferred
Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.
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