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 recent 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 Adaptable 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/4lrwur