*Hi,  *


*Hope you’re doing well!*

*This is Chintan from Inficare Technologies, please find the job
description if you are interested for this below job reply to this email ID
chin...@inficaretech.com <chin...@inficaretech.com> with your updated
resume and active contact number and best time to reach you.*


*Interview Mode: 1st Phone and 2nd Face to Face Interview.*


*Role :* Validation Analyst

*Location :* Cincinnati, OH (%100 Onsite Position)

*Duration :* 6+ Months

*Client :* Syntel



*Job Description:*

·         Single point of contact between Buyer and Supplier project teams
for project management activities

·         Coordinate between Buyer stakeholders, SMEs and Supplier offshore
team

·         Undergo the primary knowledge transfer of CSV activities and
train the offshore team

·         Responsible for planning and conducting offshore transition &
training sessions

·         Interact with Buyer, understand their requirement & provide
delivery team with client expectations

·         Work closely with project leaders on collaborating and collecting
the right inputs

·         Support the validation of cGxP computerized systems of
enterprise.

·         Developing and managing cGxP system lifecycle documentation,
including Validation Plans, User Requirements (URS), Functional and Design
Specifications, Testing Protocols (IQ/OQ/PQ), Traceability Matrix,
Validation Reports, SOPs, Change Control Documentation, Risk Assessments,
and Validation Summary Reports.

·         Reviewing completed protocols for completeness, cGxP compliance
and data acceptability; compiles final data-pack.

·         Responsible for tracking and maintaining deliverables.





Regards

*Chintan Soni*

*InfiCare* *Technologies*| 22375 Broderick Drive #225 Dulles VA 20166 |

703-652-4449 Direct |  chin...@inficaretech.com

www.infiCareTech.com

Servicing our clients since 2001    MBE/ DBE Certified in VA, MD, PA, NJ,
NC, CA

IT Services * Application Development * Mobility Solutions

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