Regulatory Consultant @ TEC Edmonton (July 2011 - March 2018)
CEO @ GrenEx Pharms Inc. (May 2015 - January 2018)
Director of Operations @ Contract Natural Health Product Manufacturer (April 2010 - March 2011)
Director of Quality Assurance and Regulatory Affairs @ (January 2009 - April 2010)
Director of Quality Assurance @ Natural Health Product / Dietary Supplement Company (April 2007 - November 2008)
Regulatory Audit Coordinator @ Alberta Cancer Board (August 2006 - March 2007)
QA Manager @ (January 2001 - January 2004)
QA Manager @ (January 2001 - January 2004)
Quality Assurance Team Lead @ (January 2000 - January 2001)
Technician @ Alberta Research Council (November 1997 - November 1999)
Scientist @ NAEJA Pharmaceutical Inc. (March 1995 - October 1997)
Technologist I @ (September 1991 - March 1995)
John Simon Education
University of Alberta
BSc (Biological Sciences)
1986-1991
Austin O'Brien 1983-1986
John Simon Skills
21 CFR Part 11
Assay Development
Auditing
Biopharmaceuticals
Biotechnology
CAPA
CRO
Change Control
Chromatography
Clinical Development
Clinical Research
Clinical Trials
Commercialization
Drug Development
Drug Discovery
FDA
GCP
GLP
GMP
Good Manufacturing Practice (GMP)
GxP
HPLC
ISO 13485
Laboratory
Life Sciences
Lifesciences
Major Gift Development
Manufacturing
Medical Devices
Microbiology
Molecular Biology
Oncology
Pharmaceutical Industry
Product Development
Quality Assurance
Quality Auditing
Quality Control
Quality System
Regulatory Affairs
Regulatory Requirements
Regulatory Submissions
SOP
Standard Operating Procedure (SOP)
Technology Transfer
Testing
U.S. Food and Drug Administration (FDA)
V&V
Vaccines
Validation
Sales
Marketing
u.s. Food and Drug Administration Fda
Research
Management
Standard Operating Procedure Sop
u.s. Food and Drug Administration
Standard Operating Procedure
John Simon Summary
John Simon, based in Edmonton, AB, CA, is currently a President and Principal Consultant at John Simon & Associates Ltd.. John Simon brings experience from previous roles at John Simon & Associates Ltd., BlueThera Biologics Inc., TEC Edmonton and GrenEx Pharms Inc.. John Simon holds a 1986 - 1991 BSc in Biological Sciences @ University of Alberta. With a robust skill set that includes 21 CFR Part 11, Assay Development, Auditing, Biopharmaceuticals, Biotechnology and more. John Simon has 1 emails and 1 mobile phone numbers on RocketReach.
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