Hardik Soni Email & Phone Number
Senior Director, Head of GCP QA @ Lundbeck
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Hardik Soni Location
- Chicago, IL, US
Hardik Soni Work
- Senior Director, Head of GCP QA @ (May 2023 - Present)
- Director, GCP and GcLP Auditing @ (November 2022 - May 2023)
- Principal Medical, Regualtory and Clinical Quality Assurance Advisor @ (May 2019 - November 2022)
- Manager, Clinical Quality Assurance @ (February 2018 - May 2019)
- Senior Program Manager @ (February 2017 - February 2018)
- Associate Program Manager @ (June 2014 - January 2017)
- GCP Vendor Compliance Auditor @ (September 2012 - June 2014)
- Senior GLP Quality Auditor @ (June 2008 - August 2012)
- Method Validation Chemist @ (December 2005 - September 2006)
- QA Specialist @ (January 2000 - May 2008)
Hardik Soni Education
- University of Illinois Chicago
Biochemistry (Biochemistry)
1996-1999
Hardik Soni Skills
- Quality Assurance
- Preclinical
- 21 CFR Part 58
- OECD
- 21 CFR Part 11
- Clinical Research
- GLP
- GCP
- ICH-GCP
- 21 CFR Part 50
- 21 CFR Part 56
- 21 CFR Part 312
- CRO
- IRB
- Quality System
- GMP
- 21 CFR Part 210
- 21 CFR Part 211
- Pharmaceutical Industry
- FDA
- CAPA
- Laboratory
- Validation
- Testing
- Change Control
- Regulatory Affairs
- Biotechnology
- HPLC
- Analytical Method Validation
- Quality Assurance Professionals
- GxP
- LIMS
- Clinical Development
- Analytical Method
- Ich Gcp
- Program Management
- Project Management
- eCRF
- Strategic Planning
- Investigator Brochures
- Clinical Protocols
- CSRs
- Microsoft Excel
- Customer Service
Hardik Soni Summary
- Hardik Soni, based in Chicago, IL, US, is currently a Senior Director, Head of GCP QA at Lundbeck. Hardik Soni brings experience from previous roles at Lundbeck, Astellas Pharma and Takeda. Hardik Soni holds a 1996 - 1999 Biochemistry in Biochemistry @ University of Illinois Chicago. With a robust skill set that includes Quality Assurance, Preclinical, 21 CFR Part 58, OECD, 21 CFR Part 11 and more. Hardik Soni has 1 emails and 1 mobile phone numbers on RocketReach.
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