Summary Experienced, Self-motivated and Results-Oriented Quality professional with >25 years in the biotech/pharma and medical device industries. Experience hosting FDA and international regulatory agencies. In depth knowledge of compliance to 21 CFR parts 210 and 211, 21 CFR Part 11, 21 CFR part 820, ISO 13485, ICH Q1A-F, Q7, Q8, Q9, Q10, USP, EP, JP Testing. Knowledge and experience with GxP auditing. Chemical and Microbial assays, LAL, Endotoxins, Sterility Testing and Environmental Monitoring Testing., Stability Testing, Design Control experience (DHF development). expertise Subject matter expert in Validation (Equipment, Cleaning and Process and CSV), Quality Systems Implementation, Maintaining Quality Management System (QMS), Compliance and Regulatory Audit Hosting, Laboratory Management, Auditing, Fermentation, Mammalian Cell Culture Manufacturing, Microbiology, Sterilization. Use of LIMS, LMS, SAP. Thorough root cause investigation methodology (6M, 5 Why). Investigations CAPA Complaints Laboratory Investigations OOS.

Highlights:

• Validation
• Lab Management
• QMS
• Compliance
• Pharmaceutical
• DS
• DP
• Research and Development
• Microbiology
• Manufacturing