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
- 2023 -now Senior Director, Head of GCP QA @
- 2022 -2023 Director, GCP and GcLP Auditing @
- 2019 -2022 Principal Medical, Regualtory and Clinical Quality Assurance Advisor @
- 2018 -2019 Manager, Clinical Quality Assurance @
- 2017 -2018 Senior Program Manager @
- 2014 -2017 Associate Program Manager @
- 2012 -2014 GCP Vendor Compliance Auditor @
- 2008 -2012 Senior GLP Quality Auditor @
- 2000 -2008 QA Specialist @
- 2005 -2006 Method Validation Chemist @
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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