Global Aseptic Processing Lead and Regional Process Validation Lead @ (July 2018 - October 2020)
Director Technical Services @ (November 2015 - August 2016)
Director of Quality Engineering @ (August 2008 - November 2015)
Director of Quality Engineering and Quality Systems @ (September 2011 - November 2012)
Senior Validation Manager @ (January 2005 - August 2008)
Owner @ Compliance Nt (January 2002 - August 2005)
Project Manager @ (September 2000 - January 2002)
Senior Scientist @ (April 1997 - September 2000)
Validation Engineer Ii @ (September 1995 - April 1997)
Validation Engineer @
Tom Elefante Education
Widener University
Bachelor of Science (Civil Engineering)
1990-1994
Tom Elefante Skills
Six Sigma
Technology Transfer
FDA
Validation
Sop
CAPA
Change Control
GMP
V&V
21 CFR Part 11
Pharmaceutical Industry
Biotechnology
Quality Assurance
Quality System
Quality Control
Computer System Validation
Cleaning Validation
Biopharmaceuticals
Medical Devices
Manufacturing
Sterilization
Cross-functional Team Leadership
GLP
Aseptic Processing
GxP
Lifesciences
Regulatory Affairs
ISO 13485
LIMS
Regulatory Requirements
Trackwise
Quality Auditing
FDA GMP
GAMP
Design Control
Microbiology
Process Simulation
Vaccines
Standard Operating Procedure (SOP)
Verification and Validation (V&V)
Corrective and Preventive Action (CAPA)
U.S. Title 21 CFR Part 11 Regulation
U.S. Food and Drug Administration (FDA)
Cross Functional Team
Verification and Validation V&V
Data Validation
Engineering
Corrective and Preventive Action Capa
Cross Functional Team Leadership
u.s. Food and Drug Administration Fda
Standard Operating Procedure Sop
Cfr
Computer System
Standard Operating Procedure
Verification and Validation
Corrective and Preventive Action
u.s. Food and Drug Administration
Tom Elefante Summary
Tom Elefante, based in New Jersey, United States, is currently a Director, Quality Assurance, External Operations at Gilead Sciences. Tom Elefante brings experience from previous roles at Halo Pharmaceutical, Inc., Novartis, G&w Laboratories and DPT Laboratories. Tom Elefante holds a 1990 - 1994 Bachelor of Science in Civil Engineering @ Widener University. With a robust skill set that includes Six Sigma, Technology Transfer, FDA, Validation, Sop and more. Tom Elefante has 2 emails and 6 mobile phone numbers on RocketReach.
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