Role & responsibilities
- Perform Microbial Limit Testing (MLT) and Microbial Enumeration Testing.
- Conduct Sterility Testing for raw materials, in-process samples, and finished products.
- Perform Bacterial Endotoxin Testing (BET).
- Carry out microbiological testing of Purified Water (PW) and Water for Injection (WFI).
- Perform microbiological testing and monitoring of utilities, including Nitrogen, Pure Steam, and Compressed Air.
- Conduct Environmental Monitoring, including Air Monitoring and Surface Monitoring, in cleanroom and controlled areas.
- Prepare, sterilize, and manage culture media as per approved procedures.
- Perform Microbial Identification and maintain related documentation.
- Conduct Disinfectant Efficacy Studies / Disinfectant Qualification Studies.
- Support microbiological monitoring activities in aseptic and injectable manufacturing areas.
- Ensure compliance with GMP, GLP, SOPs, and applicable regulatory guidelines.
- Maintain accurate records,



logbooks, test reports, and laboratory documentation.
- Support investigations related to deviations, OOS/OOT results, contamination incidents, and environmental monitoring excursions.
- Ensure proper cleaning, maintenance, calibration, and operation of microbiology laboratory equipment.
- Follow data integrity, laboratory safety, and positive documentation practices.

Preferred candidate profile
- Experience in Pharmaceutical Injectable and Biosimilar Manufacturing.
- Hands-on knowledge of Sterility Testing, BET, MLT, Environmental Monitoring, and Microbial Identification.
- Understanding of aseptic practices and cleanroom monitoring.
- Good knowledge of GMP, GLP, GDP, and microbiological laboratory practices.
- Good documentation, analytical, and communication skills.

📌 Officer/ Jr. Officer (Bhopal)
🏢 Eris
📍 Bhopal