Role & responsibilities

Microbiological Testing
- Perform microbial analysis of raw materials, in-process samples, finished products, and stability samples.
- Conduct sterility testing, microbial limit testing, bioburden testing, bacterial endotoxin testing (BET/LAL), and growth promotion testing.
- Perform media preparation, culture maintenance, and microbiological identification activities.

Environmental Monitoring (EM)
- Execute environmental monitoring of sterile manufacturing areas, including:
- Air sampling
- Surface monitoring
- Personnel monitoring
- Compressed gas monitoring
- Trend and review EM data and report any adverse findings.

Utility Monitoring
- Perform microbiological monitoring of:
- Purified Water (PW)
- Water for Injection (WFI)
- Clean Steam
- Compressed Air and Gases
- Ensure timely reporting of utility monitoring results.

Laboratory Compliance
- Maintain laboratory documentation as per GDP and cGMP requirements.
- Ensure calibration and qualification status of microbiology laboratory equipment.
- Participate in laboratory investigations, OOS, OOT,



deviations, CAPA, and change control activities.

Data Review & Documentation
- Prepare and review microbiological test reports.
- Maintain logbooks, test records, worksheets, and electronic documentation.
- Ensure compliance with ALCOA+ data integrity principles.

Regulatory & Quality Compliance
- Follow cGMP, GLP, and aseptic practices.
- Support internal audits, customer audits, and regulatory inspections (USFDA, MHRA, EU GMP, WHO, etc.).
- Participate in training and continuous improvement initiatives.

Preferred candidate profile -
- Sterility Testing
- Environmental Monitoring
- Microbial Limit Testing
- Bioburden Testing
- Bacterial Endotoxin Testing (LAL)
- Growth Promotion Testing
- Utility Monitoring (PW/WFI)
- Aseptic Practices
- OOS/OOT Investigation
- CAPA Management
- cGMP, GLP, GDP Compliance
- Data Integrity (ALCOA+)

Desired Competencies
- Robust analytical and problem-solving

📌 Walking Interview QC Microbiology (Dewas)
🏢 Gufic Biosciences
📍 Dewas