Hardik Soni
Senior Director, GCP QA - RQAP-GCP; ASQ-CQA
- Role
- Senior Director, Head of Gcp Qa at Lundbeck
- Location
- Chicago, IL, US
- LinkedIn followers
- 500 followers
About Hardik Soni
Quality Professional with background in GCP/GLP auditing, quality assurance, product testing, and method validation. Expertise in ICH E6, 21 CFR Parts 50, 56, 312, 58, OECD, cGMP Part 210 & 211.Specialties: Clinical Investigator Sites, Clinical Vendors, Central Laboratories, CRO and Systems Audits. GLP audits and Regulatory Inspection Readiness.
Experience
Senior Director, Head of Gcp Qa
May 2023 — Present · Deerfield, IL, US
Education
University of Illinois Chicago
Biochemistry
1996 — 1999
Skills
- Pharmaceutical Industry
- Fda
- Clinical Protocols
- 21 Cfr Part 312
- 21 Cfr Part 210
- Lims
- 21 Cfr Part 58
- Clinical Development
- Clinical Research
- Capa
- Hplc
- 21 Cfr Part 211
- Gmp
- Investigator Brochures
- Csrs
- Irb
- CRO
- 21 Cfr Part 56
- Laboratory
- Gcp
- Quality Assurance Professionals
- Oecd
- Change Control
- Preclinical
- Analytical Method Validation
- Validation
- Glp
- Regulatory Affairs
- 21 Cfr Part 11
- Gxp
- Quality Assurance
- Testing
- 21 Cfr Part 50
- Quality System
- Ich-Gcp
- Biotechnology
- Ecrf
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