Quality Control
6 months ago
1) Organize Microbiological testing and release of different type of samples i.e. raw materials, finished product, commercial stability, exhibit stability, miscellaneous samples.
2) Organize Microbiological testing and release of Raw / Potable / Purified water samples.
3) Monitor compliance with the requirements of approved procedures.
4) Review of departmental records.
5) Organize Microbial Environmental Monitoring of passive air/active air/ compressed air/equipment surfaces /personnel monitoring & drain points of manufacturing associated environment of Manufacturing blocks, ware houses & Microbiology lab.
6) Ensures that the Monitoring of the calibration program of equipment is done.
7) Organize handling & maintenance of microbial cultures. Isolation and identification of microbial isolates from various sources. Ensure effective system for maintaining microbial cultures.
8) Participate in the investigation of out-of-Specification results, out of trends results, conduct investigation for root cause analysis/corrective actions and systems to ensure compliance to quality requirement. Handling of Change control and CAPA management.
9) Participate in external and/or regulatory inspections of Microbiology operations at the site.
10) Ensure preparation of trend and annual summary reports of Raw/Potable/Purified water/Microbial environmental monitoring/Microbial isolates etc.
11) Ensure compliance to cGMP/GLP and applicable safety standards in the Microbiology laboratory.
Dosage Form:
- Injectables/Sterile
Pay: ₹250,000.00 - ₹480,000.00 per year
**Experience**:
- total work: 4 years (required)
Work Location: In person
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