- Provide guidance and oversight to QC microbiology and environmental monitoring staff.
- Administer the environmental monitoring program throughout the facility.
- Ensure training of microbiology and environmental monitoring programs is up to date.
- Lead investigations using structured tools: RCA, 5-Why, fishbone, fault tree, data analysis, and interviews
- Assess product and equipment impact for deviations and contamination events
- Develop and document CAPAs, evaluating their effectiveness over time
- Facilitate process hazard analysis (PHA, HAZOPs, what-if/checklist, FMEA, and human factors
- Support asset integrity, ensure equipment is designed to code, inspected, tested, maintained
- Manage change program, review changes, assess safety impacts, update safeguards