QC Microbiologist injectable background (Roorkee)

- Sterility Testing: Conducts membrane filtration or direct inoculation tests on finished injectable products to guarantee they are free from viable microorganisms.
- Environmental Monitoring (EM): Performs routine sampling of air (active and passive settling plates), surfaces (swab/contact plates), and personnel (glove prints) in Grade A/B aseptic manufacturing areas.
- Bacterial Endotoxin Testing (BET): Executes kinetic-turbidimetric or gel-clot methods (LAL test) to ensure injectable products and water for injection (WFI) are within acceptable endotoxin limits.
- Water System Monitoring: Tests WFI systems, purified water, and clean steam for bioburden and endotoxins.
- Microbial Identification: Identifies microorganisms recovered during EM or sterility failures using biochemical and molecular methods.
- Media Preparation & Growth Promotion Testing (GPT): Prepares microbiological culture media and validates its ability to support microbial growth before use.
- Quality Management & Documentation: Handles QMS tasks such as deviations, Out of Specification (OOS) investigations, Out of Trend (OOT) reporting, and CAPA (Corrective and Preventive Actions).
- Validation & Method Transfer: Performs method validation for sterility tests, endotoxin tests, and bioburden testing for new or updated products. [1, 2, 3, 4, 5, 6, 7] Key Requirements & Skills
- Experience: Previous experience in a sterile manufacturing or parenteral drug lab is typically required.
- Knowledge: Strong understanding of USP, EP, and JP pharmacopoeia methods.
- Gowning Qualification: Must be trained in aseptic gowning protocols to enter cleanrooms.
- Software: Experience with Lab Information Management Systems (LIMS), SAP, or MODA. Job Types: Full-time, Permanent Pay: ₹22,000.00
- ₹45,000.00 per month Advantages:
- Commuter assistance
- Flexible schedule
- Food provided
- Health insurance
- Life insurance
- Paid sick time
- Provident Fund Education:
- Bachelor's (Required) Experience:
- Microbiology: 3 years (Required) Work Location: In person Apply on Kit Job: kitjob.in/job/4lha0h