Personal Information
Organization / Workplace
Mumbai Area, India, Haryana India
Occupation
Head of Clinical Safety and Regulatory Technology Services
Industry
Technology / Software / Internet
Website
http://clinicalserver.comAbout
- Knowledge in Validation(IT Systems)/GxP regulations/21 CFR Part 11/FDA Guidelines
- Knowledge of Computer Systems Validation, System Development Life Cycle, and GAMP5 guidelines
- Experience in handling internal & external compliance audits.
- Experience in facilitating & coordinating cross-functional teams.
- Experience in managing requirements traceability information and track requirements status throughout the project and translating these to a functional specifications document.
- As a Senior Oracle DBA, Oracle 11g RAC DBA, ASM, RMAN and Data-guard, worked on almost all Oracle DB versions released so far in the heterogeneous, high availability, mission critical applications databas...
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