13 Oct
|
Indus Pharma
|
Neemrana
13 Oct
Indus Pharma
Neemrana
– 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
Benefits
- Food provided
- Health insurance
- Provident Fund
Work Location: In person
📌 QC- AMV (Neemrana)
🏢 Indus Pharma
📍 Neemrana