Siddharth Jain
CSV I CSA I GxP Governance, Risk & Compliance I Project Management I SDLC I Validation I GAMP I QMS
- Role
- Senior Consultant (Lead Csv & IT Compliance) at Infosys
- Location
- Hyderabad, IN
- LinkedIn followers
- 500 followers
About Siddharth Jain
End to End CSV/ITQA implementation and lead Process and Domain Consuting. Project…
Experience
Senior Consultant (Lead Csv & IT Compliance)
Jun 2022 — Present · Hyderabad, IN
Lead CSV and IT Quality for enterprise digitization projects.• Planning, scheduling, implementation, and managing CSV projects and Enterprise Applications such as TrackWise, DMS, and SAP in the Pharma and Life Sciences industry.• Been an expert, author, reviewer, and IT quality for the CSV and SDLC activities.• Perform vendor assessments and take part in vendor qualification activities.• Managing Regulatory and Customer audits• Conduct Assessments, identify risks and derive mitigation plans to overcome the compliance risks.• Author and/or review of CSV deliverables that typically includes GxP Assessment, VP, FRA, TM and VSR as per organizational SDLC framework, regulatory requirements and GAMP 5 guidance.• Managing periodic reviews, audit trail review, user access management, and ER ES assessments.• Leading regulatory compliance initiatives involving 21 CFR Part 11, GAMP 5, audit readiness, and quality reviews.• Experienced in handling defects/discrepancy identified during the project.• Co-ordinating and managing the team members and timely updation of work status through daily / weekly meetings.• Authoring and/or Review of SOPs and Managing trainings related to CSV, Quality Compliance and Operation of Computerized systems.
Skills
- Gmp
- Quality Assurance
- Sop
- Formulation
- Pharmaceutics
- Regulatory Affairs
- Microsoft Office
- Powerpoint
- Glp
- Microsoft Excel
- Validation
- Pharmaceutical Industry
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