Vikas Jamdhade
Computer System Validation (CSV) | SDLC | Life Science | pharmaceutical | GxP | USFDA 21 CFR Part 11 | EU Annex 11 | Risk Assessment
- Role
- Validation Engineer at Tata Consultancy Services
- Location
- Pune, IN
- LinkedIn followers
- 500 followers
About Vikas Jamdhade
I have 6 years experience in computer system validation in the pharmaceutical industry…
Experience
Validation Engineer
Dec 2021 — Present · Pune, IN
Four years three month of computer system validation experience in the pharmaceutical industry. Understanding of GXP standards, 21 CFR Part 11, EU Annex 11, GAMP 5. Hands on experience in performing IQ, OQ testing for equipment. Have worked on various process Machine of Manufacturing, Quality Control (QC) and packing facilities. Having Knowledge of Quality Control laboratory instrument software projects like CDS Software (Empower 3 Software, chromeleon Software). Non-CDS software (Aetron Software, UV Winlab Software, TOC V Software, TOC-L Software, Enviro Stability Software, IR Solution Software, UV Probe Software, Lab Solution Software, Tiamo Software, Mastersizer Software, Pyris Software, Lab India software, Newtronic ICDAS2.1 software, Lab Solution server and client software, Biometric Attendance Device etc.).Production & Packing instrument Software project like propix Trackn Trace, Tablet Compression machine (fette).Having experience of Clinical trail VBA based macros like SDTM macro, PWT Macro, ECRF file renaming macro, Vendor MUL Macro, VCST/DCSU Macro. Preparing and review the validation document like BRD, RCA, VP, CCF, IOQP, RTM, VSR, MDL.
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