Benhur Benjamin
- Role
- Director, IT Compliance at Syneos Health
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Benhur Benjamin
RAC-credentialed leader with deep expertise in computer systems quality (CSQ) and…
Experience
Director, IT Compliance
Sep 2023 — Present
Represent IT in Quality and Regulatory Audits: Primary POC for IT, demonstrating a deep understanding of compliance requirements. Compliance Program Administration: Oversee the program, ensuring its evolution in accordance with changing regulatory and industry standards. Internal and External Audits: Evaluate IT processes and systems for compliance and assess adequacy of vendors\' processes and systems against quality and regulatory requirements.
Education
Allahabad Agricultural Institute
Bachelor of Technology, Agricultural Engineering
1984 — 1988
University of Maryland
M.S., Bioengineering
1994 — 1998
Kelley School of Business Indianapolis
Master of Business Administration - MBA, Business Administration and Management, General
2008
Skills
- Commercialization
- V&V
- Iso 13485
- Clinical Trials
- Pharmaceuticals
- Quality Control
- Software Documentation
- Medical Devices
- Pharmaceutical Industry
- Fda
- Process Auditing
- Gcp
- Sharepoint
- Sop
- Gmp
- Oncology
- Gamp
- Technology Transfer
- Regulatory Requirements
- Lifesciences
- Quality Management
- Gxp
- Quality System
- Manufacturing
- IT Infrastructure Qualification
- Quality Auditing
- Hardware Diagnostics
- Strategy
- Computer System Validation
- Biopharmaceuticals
- Quality Assurance
- Regulatory Submissions
- Design Control
- Clinical Research
- Biotechnology
- R&D
- Iso
- Quality Systems
- 21 Cfr Part 11
- Business Process
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