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

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