17 Oct
|
Indus Pharma
|
Neemrana
17 Oct
Indus Pharma
Neemrana
Job Description – QC (AMV)
Department: Quality Control – Microbiology
Position: Officer / Executive – AMV
Industry: Liquid Injectable Manufacturing
Key Responsibilities
Perform environmental monitoring in Grade A, B, C, and D areas as applicable.
Conduct viable monitoring: active air sampling, settle plates, surface monitoring, and personnel monitoring.
Perform non-viable particulate monitoring using particle counters, as assigned.
Ensure monitoring during aseptic operations, interventions, and media fills as per approved procedures.
Check microbiological media status, GPT compliance, incubation conditions, and sample traceability.
Record results accurately and maintain logbooks and GMP documentation.
Immediately report alert/action limit excursions and participate in investigations, root-cause analysis, and CAPA.
Perform equipment cleaning and verify calibration/qualification status.
Follow cGMP, aseptic practices, data integrity (ALCOA+), SOPs, and the site's Contamination Control Strategy (CCS).
Support environmental monitoring trend analysis, audits, and regulatory inspections.
Qualification
B.Sc./M.Sc. in Microbiology, Biotechnology, or a relevant life-science discipline.
Experience
1–4 years of experience in QC Microbiology/Environmental Monitoring in a sterile injectable facility, preferably with Grade A/B exposure.
Significant Notes
Follow approved sampling locations, frequencies, limits, and procedures.
Report excursions immediately; do not independently close investigations.
Ensure proper gowning, aseptic behavior, and contamination prevention.
Maintain complete, accurate, and contemporaneous documentation.
Comply with applicable GMP requirements, including EU GMP Annex 1 where applicable.
Pay: ₹8,800.00 - ₹47,000.00 per month
Perks:
Food provided
Health insurance
Provident Fund
Work Location: In person
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🏢 Indus Pharma
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