Jinit P.
- Role
- Associate Director, Head of Digital Quality and Data Integrity at Agios Pharmaceuticals
- Location
- Cambridge, MA, US
- LinkedIn followers
- 500 followers
Experience
Associate Director, Head of Digital Quality and Data Integrity
Jun 2021 — Present
Responsible to help ensure Agios selects, implements, and maintains GXP computer systems in compliance with US, MHRA and EMA regulations and industry best practices.\\\\nDefine the strategy and provide QA oversight of computer systems validation and audit activities.\\\\nSupport the data integrity, IT security, and risk management of computer systems.
Education
University of Florida
Master's Degree, Chemical Engineering
University of Mumbai
Bachelor's Degree, Chemical Engineering
Skills
- Testing
- Documentation
- Training & Development
- Glp
- Fit/Gap Analysis
- Vendor Audit
- Regulatory Requirements
- Chromatography Data Systems
- Agile & Waterfall Methodologies
- 21 Cfr Part 11
- Audit Trail
- Incident Management
- Computer System Validation
- Sop
- Regulatory Compliance
- Electronic Lab Notebooks
- Gmp
- Sop Development
- Capa
- Validation
- Gamp
- Repository Management
- Lims
- Requirements Analysis
- Gxp
- Risk Analysis
- Quality Assurance
- 21 Cfr Part 11 210 211
- Ich Guidelines
- Full Sdlc
- Requirements Gathering
- Fda
- Regulatory Analysis
- Adverse Event Reporting
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