Pharmaceutical | Biotechnology | Medical Device and In-Vitro Diagnostics
- Assisted in PAI preparation by reviewing technical data and training personnel in FDA response techniques
- Assisted with Drug Master File preparation
- Facilitated remediation of FDA warning letter citations
- Validated manufacturing, lab, and process equipment, software, and hardware
- Implemented quality systems for clinical and commercial manufacturing
- Performed GCP monitoring and conducted audits at clinical sites
- Performed well over 50 internal and external audits of sites, suppliers and contractors annually
- Established quality systems and served as QA manager/director for virtual companies
- Wrote investigation reports for deviations and non-conformances
- Acted as QA Director for 4 months
- Performed customized and general GMP and compliance training
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