2018 -2020 Global Aseptic Processing Lead and Regional Process Validation Lead @
2015 -2016 Director Technical Services @
2008 -2015 Director of Quality Engineering @
2011 -2012 Director of Quality Engineering and Quality Systems @
2005 -2008 Senior Validation Manager @
2002 -2005 Owner @ Compliance Nt
2000 -2002 Project Manager @
1997 -2000 Senior Scientist @
1995 -1997 Validation Engineer Ii @
now 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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