Frank Giampetro
Associate Director Quality Validation
- Role
- Associate Director Quality Validation at ProKidney Corp.
- Location
- Winston-Salem, NC, US
- LinkedIn followers
- 500 followers
About Frank Giampetro
My years of Pharmaceutical Validation experience; answering to both Quality Assurance and Engineering allows me to bring a breadth and depth of practical real world knowledge to any team. I bring that knowledge and experience to bear in a leadership role every day. Providing guidance and direction, leading to quality oriented, yet risk based solutions. I also have audit experience with the FDA, the EMA, and with a Qualified Person from the EU.My objective is to continue to expand my knowledge and responsibility with expanding leadership roles within Technical Operations / Quality Assurance / Validation Departments.
Experience
Associate Director Quality Validation
Apr 2024 — Present · Winston-Salem, NC, US
Education
Lindenwood University
Bachelor of Science - BS, Information Technology
Skills
- Quality Assurance
- Corrective and Preventive Action (Capa)
- Good Laboratory Practice (Glp)
- Validation
- Standard Operating Procedure (Sop)
- Quality System
- V&V
- Glp
- Trackwise
- Cleaning Validation
- Gamp
- Technology Transfer
- Gmp
- Pharmaceutical Industry
- Sop
- Fda
- Medical Devices
- Capa
- Computer System Validation
- 21 Cfr Part 11
- Change Control
- Biopharmaceuticals
- Verification and Validation (V&V)
- U.s. Title 21 Cfr Part 11 Regulation
- U.s. Food and Drug Administration (Fda)
- Gxp
- Aseptic Processing
- Bulk
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