Harsh V Thakkar from Apex, NC, age 39

Resumes

Associate Director, Qa Gxp Electronic Systems And Data Integrity

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Location:

Bellevue, WA

Industry:

Biotechnology

Work:

Cytokinetics
Associate Director, Qa Gxp Electronic Systems and Data Integrity
Celgene
Senior Manager, Quality Assurance -Esystems and Data Integrity
Celgene Sep 2018 - Mar 2019
Manager, Technical Quality- Esystems
White Collar Technologies, Inc Feb 2012 - Aug 2018
Senior Manager, Computer System Validation and It Quality Assurance
Dr. Reddy's Laboratories Feb 2010 - Feb 2012
Regulatory Affairs Analyst

Education:

Infoserve Technical Institute 2011 - 2012
St. John's University 2010
Master of Science, Masters University of Mumbai May 2007
Bachelors, Bachelor of Science University of Mumbai 2003 - 2007
Bachelors, Pharmacy New York University
Master of Science, Masters St. John's University
Masters

Skills:

Validation
Quality Assurance
Fda
Sop
Gmp
21 Cfr Part 11
Regulatory Affairs
Computer System Validation
Capa
Change Control
Pharmacovigilance
Glp
Cgmp
Ectd
Software Validation
Requirements Specification
Gcp
Full Sdlc
Risk Assessment
Pharmaceutical Industry
Risk Management
Quality Management
Quality System
Regulatory Submissions
Project Management
Strategic Planning
Biotechnology
Quality Auditing
It Service Management
Program Management
Team Leadership
Management
Cross Functional Team Leadership
Leadership
Data Integrity
Ich Gcp
Gxp
Gamp
Mhra
Cell Therapy
Gene Therapy
Information Security Management
Itil

Interests:

Playing Squash
Children
Environment
Education
Gourmet Cooking and Traveling
Science and Technology
Music
Running
Animal Welfare
Health

Languages:

English
Hindi
Gujarati

Certifications:

Cyberwar, Surveillance and Security
Computer Programming- Specific Applications (Oracle Sql and Sas 9.2)
Innovation and It Management
Registered Pharmacist
Maharashtra State Pharmacy Council, Maharashtra, India