Naveen T R
II Computer System Validation (CSV) II II Project Quality Management II II IT Compliance II II Data Integrity II II Regulatory Compliance (FDA 21 CFR Part 11, EU Annex-11) II II System Lifecycle Documents (SLDC) II
- Role
- Technology Analyst at Infosys
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Naveen T R
Welcome to my LinkedIn! I am Naveen T R a highly skilled IT Consultant with…
Experience
Technology Analyst
Jan 2023 — Present · Bengaluru, IN
Working as a PQM (Project Quality Manager) wherein ensuring ERP IT, project governance, quality and compliance standards as well as relevant internal/external requirements (GXP,SOX, Data Privacy & so on) are adhered during projects Training and coaching the Project Team, as required, on relevant project procedures, good documentation practice, good testing practice and CSV basics Maintaining the project risk register for all ongoing projects, performing root cause analysis on trends and addressing deviations via preventive, detective and corrective measures to enhance PQM\'s deliverable • Participating in compliance audits related to GXP and SOX controls; providing required information related to audit findings, deviation management, RCA & CAPA • Steering timely creation, review and approval of all project documents and System Lifecycle Documents (SLCD) as per the project phases Executing process & validation consulting; authoring & reviewing validation plan, validation report, traceability matrix and system lifecycle documents (IQ, OQ, PQ) Reviewing and validating Data Migration Workbook (DMW) such as data verification test scripts and execution results (DVT) Ensuring critical or confidential project information is stored safely in restricted storage locations and no information of project is disclosed or shared outside the project which has signed Non-Disclosure Agreement Reviewed and approved system lifecycle documents like UD, FS, DD, IQ, OQ and PQ Managed quality and compliance in Pharma industries, Pharmacovigilance, Drug Development, GAMP, 21 CFR Part 11,Annexure 11,GXP and CSV Documentation, System Validation and SOX * Reviewed and approved system life cycle documents like UD, FS, DD, IQ, OQ and PQ Managed quality and compliance in Pharma industries, Pharmacovigilance, Drug Development, GAMP, 21 CFR Part 11,Annexure 11,GXP and CSV Documentation, System Validation and SOX
Education
St.Clarets PU College
P U
2006 — 2008
Standard English School
SSLC
2003 — 2006
SYMBIOSIS INTERNATIONAL UNIVERSITY
Master's degree
2013 — 2015
Acharya Institute of Management and Science, Ist Stage, Peenya Industrial Estate, Bangalore-58
Bachelor’s Degree
2008 — 2011
Skills
- Sales Operations
- Auditing
- Sap Fi
- Accounting
- Microsoft Excel
- Financial Accounting
- Bookkeeping
- Accounts Payable
- Account Reconciliation
- Financial Analysis
- Quickbooks
- Indirect Taxation
- Accounts Receivable
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.