Avanish Raj
Experience in ERP, Cloud Based, Infrastructure, Document Management Systems and IT CSV Audit. Thorough knowledge of GAMP5, Annex 11, 21 CFR Part 11, 210, 211 and 820; ALCOA principles and Data Integrity.
- Role
- Q & C Manager at IDEAYA Biosciences
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
Experience
Q & C Manager
May 2025 — Present
Quality and Compliance focused work
Education
Sarojini Devi Eye Hospital
Diploma in Optometry, Optometry
Osmania University
Bachelor's degree, Maths, Physics and Chemistry
Ken Informatics
Postgraduate Diploma in Computer Science
Indiana University Bloomington
A.S in Optometric Technology Program, Optics/Optical Sciences
University of Bradford
Post Graduate Certificate, Optmetry
Skills
- Requirements Analysis
- Validation
- Quality Assurance
- Quality and Compliance
- Cgmp
- Quality Systems
- Document Management
- Gxp
- Sdlc
- Gmp
- Compliance Management
- Problem Solving
- Software Quality Assurance
- Change Control
- Gmp and Gcp Applications
- 21 Cfr Part 11
- Gcp
- Microsoft Office
- Risk Management
- User Acceptance Testing
- Documentation
- Testing
- Sharepoint
- Iso
- Sop
- Fda
- Pharmaceuticals
- Regulatory Affairs
- Quality Management
- Risk Assessment
- Continuous Improvement
- Compliance
- Business Process
- Auditing
- Computer System Validation
- Test Planning
- Change Management
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