Sachin Datar
Delivery Manager - Validation and Compliance Consultancy at Tata Consultancy Services
- Role
- Delivery Manager (IT Quality & Compliance) Pharma at Tata Consultancy Services
- Location
- Mumbai, IN
- LinkedIn followers
- 500 followers
About Sachin Datar
20+ years of varied experience across domains as Life Sciences, Telecom…
Experience
Delivery Manager (IT Quality & Compliance) Pharma
Jun 2011 — Present · Mumbai, IN
Role involves Validation and compliance consultancy to various IT projects in Pharmaceutical domain for one of the Global Pharmaceutical Client of TCS.providing Quality consultancy with specific exposure to GxP, SoX, 21CFR Part 11, CSV etc.•Perform compliance risk assessment of IT & Mobile application identifying applicable compliance Domains (PI, SPI, GxP, SOX, Safe Harbor, software Medical device etc.)•Tracking and Guidance for meeting Compliance Requirements(CRS) •Review of SDLC and Validation related project documentation (Plan till deployment)•Guidance and Consultation about compliance parameters RFC\\Change Management Process, deviation, CAPA & exception management•Compliance report and Project Closure Report authoring on project completion•Awareness creation among project teams for applicable compliance areas and necessary processes like PI, SPI, Safe Harbor, GxP, SOX etc.•Periodic review of compliance status of IT applications as per organizational guidelines and follow-ups with stakeholders on related compliance.•Manage team of Quality Analyst /Consultant providing QA support.
Education
SCDL (Symbiosis Center of Distance Learning)
PGDBA, Operations
2006 — 2008
University of Mumbai
Bachelor's degree, Electrical, Electronic and Communications Engineering Technology/Technician
1996 — 2000
S H Jondhale School
SSC
Skills
- Bss
- Business Analysis
- Business Process Re-Engineering
- Etom
- Software Project Management
- Quality Assurance
- Team Management
- Business Process Improvement
- Six Sigma
- Software Development Life Cycle (Sdlc)
- Service Delivery
- Verification and Validation (V&V)
- Pre-Sales
- Visio
- Project Delivery
- Requirements Analysis
- Process Improvement
- Process Consulting
- Business Process Design
- Aris
- Agile Methodologies
- Erp
- Business Process
- Itil
- Gxp
- Telecommunications
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