- 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 databases of Pharmaceuticals, Telecom and EPC domian areas
- Data Centre Management: Managed large Data Centres as an Infrastructure Lead / technically hands on Operations Head
- Managed following Enterprise N-Tier applications on Oracle based databases:-
- Pharmaceuticals domain: Regulatory applications - Oracle Clinical, Oracle RDC, Oracle TMS, Oracle Argus, Oracle AERS, Oracle EBS, NuGenesis LIMS, EMC Documentum, GxPharma for electronic submissions, Oracle Siebel CTMS
- EPC domain Applications: Oracle based engineering application like PipeWorks, ProjectWorks , 3DM etc
- Telecom Domain Applications : Oracle based Post paid billing applications ISIS & BSCS, Pre-paid, CRM, Point of sales applications SICOM, Red brick Dataware housing support in a clustering and SAN environment
- Domain Knowledge, Pharmaceuticals, Telecom, Engineering Procurement & Construction, & continuous process plant