Amit Dangi
CSV | CSA | 21 CFR Part 11 | EU Annex 11 | GAMP 5 | V-Model | ER/ES | GxP | QMS | QRM | DI | VLMS | SDLC | STLC | Risk Assessments I IT-Compliance | Regulatory Compliance
- Role
- Validation Executive - Csv at INSTRUMENTATION AND CONTROL SOLUTIONS
- Location
- Indore, MP, IN
- LinkedIn followers
- 500 followers
About Amit Dangi
Highly Accomplished Validation Executive with over 3 years of experience in Computer System Validation (CSV), Computer Software Assurance (CSA), GxP, IT, and regulatory compliance. Skilled in ensuring that computerized systems meet functional, safety, data integrity, and security requirements in alignment with 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines. Strong background in developing, reviewing, and executing SDLC deliverables throughout the validation lifecycle, Proven experience in Quality Assurance as an Officer and Apprentice Trainee, responsible for reviewing and approving all CSV documentation, conducting IPQA checks, participating in internal audits, QMS, QRM activities, and ensuring strict adherence to industry standards and regulatory expectations.
Experience
Validation Executive - Csv
INSTRUMENTATION AND CONTROL SOLUTIONS
Apr 2025 — Present · Indore, IN
Education
University Institute of Technology, RGPV
Bachelor of Pharmacy - B Pharm, Pharmaceutical Sciences
University Institute of Technology, RGPV
Master of pharmacy - M Pharm, Pharmaceutical Sciences
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