We are looking for an Approved Microbiologistfor our OSD (Oral Solid Dosage) manufacturing facility. The candidate must be approved by State FDA / Drug Authorityand responsible for all microbiological quality control activities, ensuring compliance with WHO-GMPand regulatory requirements.
Key Responsibilities:
- Environmental Monitoring (EM) of production and controlled areas
- Water testing (Purified Water, RO, etc.) including microbial load analysis
- Personnel monitoring and hygiene verification
- Microbial analysis of raw materials, finished products, and stability samples
- Growth Promotion Test (GPT), media preparation, and culture handling
- Handling of microbial deviations, OOS, and investigations
- Trend analysis of EM and water results
- Maintenance of microbiology lab records and documentation
- Ensuring compliance with SOPs, GLP, and data integrity practices
- Participation in audits and regulatory inspections
Mandatory Requirement:
- Must be an Approved Microbiologist as per State FDA norms
- Approval certificate required at the time of application
Required Skills:
- Strong knowledge of microbiological techniques and aseptic practices
- Hands-on experience in EM, water systems, and contamination control
- Familiarity with WHO-GMP, Schedule M, and regulatory guidelines
- Good documentation and investigation skills
Qualifications:M.Sc / B.Sc in Microbiology or relevant life sciences
Preferred Profile:
- Experience in OSD (Tablet, Capsule, Dry Syrup) manufacturing facility
- Exposure to audits (WHO-GMP / regulatory inspections)
- Strong ownership and accountability mindset
Job Types: Full-time, Permanent
Pay: ₹28,000.00 - ₹32,000.00 per month
Benefits:
- Health insurance
- Provident Fund
Work Location: In person
