Siddharth Vyas
CSV Life Sciences | GxP | 21 CFR Part 11 | GAMP 5 | QMS | Good Manufacturing Practices | IT Compliance | Senior Specialist - Quality Engineering
- Role
- Senior Specialist Quality Engineering at LTIMindtree
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Siddharth Vyas
To Perform, Review and assist for End to End CSV Projects to the Life Sciences Domain.• Designing, Preparation and review of all deliverables related to Computerized System Validation. • Authoring, Review of the SOPs related to CSV-IT Compliance and training to the concern teams.• To co-ordinate with CQA Dept. and follow the QMS Procedures into the IT Dept.• CSV for all GxP Impacting Business Applications like Laboratory Instruments Systems, Manufacturing Computerized Systems and other application systems to comply with regulatory guidelines. • Assist for the System Administration for the Laboratory Instruments System and Process Control Systems (when required).• Responsible for Periodic Review, Automatic and Manual Backup Logs Verification.• Responsible to provide the KT, to the team and come up to the speed, to deliver the project in time.
Experience
Senior Specialist Quality Engineering
Nov 2024 — Present · Pune, IN
Education
B H Gardi College of Engineering & Technology
Bachelor of Engineering (BEng)
2009 — 2013
Home School ,Bhavnagar
Higher Secondary
2004 — 2008
Skills
- Gxp
- Programming
- Plc
- Automation
- Computer System Validation
- Hmi Programming
- Instrumentation
- Step 5 Plc
- Validation
- Commissioning
- Standard Operating Procedure (Sop)
- Sop Authoring
- Microsoft Office
- Programmable Logic Controller (Plc)
- Human Machine Interface
- IT Compliance
- Scada
- Manufacturing
- Testing
- Microsoft Excel
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