Microbiology Officer
4 days ago
Key Responsibilities:
- Perform routine microbiological testing of raw materials, in-process samples,
finished products, and water systems (e.g., TOC, endotoxin, bioburden, sterility).
- Conduct environmental monitoring (viable and non-viable particle counts, surface
swabbing, personnel monitoring) in cleanrooms and controlled areas.
- Perform validation activities including media fill simulations, cleaning validation, and
method validation.
- Identify and investigate out-of-specification (OOS) and non-conformance issues in
collaboration with QA/QC.
- Maintain accurate and complete microbiological records, logs, and documentation as
per cGMP.
- Prepare microbial cultures, maintain microbial stock cultures, and carry out
identification of microorganisms.
- Participate in internal and external audits and assist in CAPA implementation related
to microbiology.
- Ensure laboratory instruments and equipment are calibrated, maintained, and
validated as per schedule.
- Assist in the development and revision of SOPs, protocols, and microbiological
methods.
- Support continuous improvement and training initiatives within the microbiology
lab.
Key Skills Required:
- Attention to detail and strong documentation practices
- Analytical and critical thinking
- Familiarity with microbiology software systems (LIMS, etc.)
- Ability to work independently and in teams
- Good communication and reporting skills
Qualification:
- B.Sc./M.Sc. in Microbiology, Biotechnology, or related field.
- 2-5 years of experience in a pharmaceutical microbiology lab, preferably sterile
manufacturing.
- Good knowledge of current Good Manufacturing Practices (cGMP), GLP, and
regulatory guidelines (e.g., WHO, EU, USFDA).
- Hands-on experience in microbial limit testing, sterility testing, and EM techniques.
- Proficiency in data recording, documentation, and handling microbiology lab
equipment.
Pay: ₹30,000.00 - ₹40,000.00 per month
Schedule:
- Day shift
**Experience**:
- Microbiology: 2 years (preferred)
- pharmaceutical microbiology lab: 1 year (preferred)
- sterile manufacturing: 1 year (preferred)
- microbial limit testing: 1 year (preferred)
- sterility testing: 1 year (preferred)
- EM techniques: 1 year (preferred)
Work Location: In person
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