Core Microbiology Testing
- Sterility Testing (Membrane filtration / Direct inoculation)
- Microbial Limit Test (MLT / Bioburden)
- Endotoxin Testing (LAL Gel clot / Kinetic / Chromogenic)
- Water analysis (PW, WFI)
- Environmental Monitoring:
- Air (Active & Passive)
- Surface & Personnel monitoring
- Media preparation, sterilization & GPT
- Culture handling, isolation & identification
Utilities & Facility Monitoring
- Cleanroom classification & trend analysis
- HVAC monitoring & interpretation
- Compressed air & gas testing (if applicable)
Documentation & Compliance
- GDP & GMP documentation
- Preparation & review of:
- SOPs
- STPs
- Protocols & reports
- OOS, OOT, deviation handling
- CAPA participation
- Audit readiness (Internal & External)
Regulatory Knowledge
- WHO-GMP
- Schedule M
- Pharmacopoeias:
- IP
- USP
- BP / EP (added advantage)
- Data Integrity principles (ALCOA+)
Computer Skills
- MS Word, Excel (trend charts, EM data)
- LIMS exposure preferred
Behavioral & Soft Skills
- Strong attention to detail
- Good analytical & troubleshooting skills
- Ability to work independently & in shifts
- Good communication & documentation skills
- Compliance-oriented mindset
Working Conditions
- Shift work as per production & QC requirements
