Microbiological Testing
- Perform microbiological analysis of:
- Raw Materials
- Water Systems (Purified Water, WFI)
- Finished Products
- In-process Samples
- Compressed Gases
- Environmental Monitoring Samples
- Conduct sterility testing, microbial limit testing, bioburden testing, endotoxin testing, and growth promotion testing.
- Review and evaluate microbiological test results for compliance with specifications. Environmental Monitoring (EM)
- Execute environmental monitoring of classified manufacturing areas including:
- Viable Air Monitoring
- Non-Viable Particle Monitoring
- Surface Monitoring
- Personnel Monitoring
- Trend environmental monitoring data and identify adverse trends.
- Support investigations of environmental excursions and microbiological deviations. Sterility Assurance & Contamination Control
- Support contamination control strategies within sterile manufacturing operations.
- Participate in media fill studies and aseptic process simulations.
- Monitor cleanroom microbiological status and recommend corrective actions when required.
- Ensure compliance with aseptic practices and cleanroom procedures. Laboratory Operations
- Prepare and manage microbiological media, reagents, cultures, and controls.
- Operate and maintain laboratory equipment such as:
- Incubators
- Autoclaves
- Biosafety Cabinets
- Particle Counters
- Endotoxin Testing Systems
- Colony Counters
- Ensure laboratory housekeeping and 5S compliance.



Investigation & CAPA Management
- Participate in investigations related to:
- OOS (Out of Specification)
- OOT (Out of Trend)
- Environmental Monitoring Excursions
- Sterility Failures
- Microbiological Deviations
- Perform root cause analysis and support implementation of CAPA.
- Monitor effectiveness of corrective and preventive actions. Documentation & Compliance
- Maintain accurate laboratory records, logbooks, worksheets, and reports.
- Ensure compliance with Valuable Documentation Practices (GDP) and Data Integrity requirements.
- Prepare and review SOPs, protocols, reports, trends, and microbiological risk assessments.
- Support qualification and validation documentation. Audit & Regulatory Support
- Participate in internal audits, customer audits, and regulatory inspections.
- Prepare and present microbiological data during audits.
- Ensure inspection readiness of microbiology laboratory and manufacturing areas.
- Support compliance with USFDA, MHRA, EU GMP, WHO-GMP, and PIC/S requirements. Training & Cross-Functional Coordination
- Provide GMP and microbiological awareness training to manufacturing personnel.
- Coordinate with Production, Quality Assurance, Engineering, Validation, and Warehouse teams.
- Support continuous improvement initiatives related to contamination control and sterility assurance. Interested candidates can send resumes to [email protected]

📌 Microbiology Officer (Guwahati)
🏢 SUN PHARMA
📍 Guwahati