Walking Interview QC Microbiology - Officer / Senior Officer

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

• Strong analytical and problem-solving skills
• Attention to detail
• Good documentation practices
• Team collaboration
• Effective communication skills
• Ability to work in shifts if required

Preferred Exposure

• USFDA, EU GMP, MHRA, WHO-GMP regulated facilities
• LIMS, TrackWise, SAP, or equivalent quality systems
• Injectable/Sterile manufacturing environment