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Pradeep A Location
Austin, TX, US
Pradeep A Work
Associate Director Quality Assurance @ (January 2023 - Present)
Business Systems Project Manager @ (January 2020 - January 2023)
Validations and Quality Assurance consultant @ (October 2018 - January 2020)
QA and Validations @ (February 2018 - January 2020)
QA and Validation Consultant @ (February 2018 - September 2018)
Compliance @ ICU Medical (February 2017 - February 2018)
Compliance @ (September 2015 - February 2017)
Compliance Investigations @ (September 2013 - September 2015)
Quality Assurance and Validation Representative @ (October 2011 - September 2013)
Regulatory Affairs Associate @ (May 2011 - October 2011)
Pradeep A Education
Northeastern University
Masters (Regulatory Affairs)
2009-2011
Osmania University
Bachelor's (Pharmaceutical Sciences)
2004-2008
Pradeep A Skills
Situational Leadership
Problem Solving
Microsoft Office
Quality Management
People Management
Risk Management
Project Management
Auditing
Communication
Quality Assurance
FDA
ISO 13485
Clinical Trials
Quality and Compliance
Compliance
Quality tools
GCP
GMP
CAPA
Regulatory Requirements
Medical Devices
Biotechnology
510(k)
PMA
IND
NDA
Pharmaceuticals
Regulatory Submissions
Regulatory Strategy Development
Regulatory Documentation
Trackwise
Information Protection Risk Management
Pharmaceutical Industry
V&V
Regulatory Affairs
Pharmaceutics
Validation
GxP
Drug Development
Pharmacovigilance
Quality Auditing
21 CFR Part 11
GLP
U.S. Food and Drug Administration (FDA)
Corrective and Preventive Action (CAPA)
Global Regulatory Compliance
Presentations
Software Project Management
Pradeep A Summary
Pradeep A, based in Austin, TX, US, is currently a Associate Director Quality Assurance at AbbVie. Pradeep A brings experience from previous roles at Flex, Alkermes, Aplomb Technologies Inc and Novo Nordisk. Pradeep A holds a 2009 - 2011 Masters in Regulatory Affairs @ Northeastern University. With a robust skill set that includes Situational Leadership, Problem Solving, Microsoft Office, Quality Management, People Management and more. Pradeep A has 2 emails and 1 mobile phone numbers on RocketReach.
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