*Dear Partner,*
*Hope you are doing fine !!*
*IT SCIENT is a highly recognized provider of professional IT Consulting
services in the US.*
*Please find the requirement below with my contact and details 510-516-7899
//vi...@itscient.com <vi...@itscient.com> //vicky.kumaritsci...@gmail.com
<vicky.kumaritsci...@gmail.com>*
*Role: **Validation Lead (Pharma domain)*
*Location: **Chicago, IL*
*Duration :- 12+Months*
*Job Description*:
*Technical/Functional Skills *
1. *Expert knowledge of and experience with regulatory agency
regulations such as FDA GLPs, predicate rules, and 21 CFR Part 11*
2. *Experience in assessing the validation strategy of IT and
infrastructures based on the defined SOP’s*
3. *Proven track record of leading the timely completion of computer
system validations.*
4. *Extensive experience authoring computer system compliance risk
validation materials in accordance with FDA GxP regulations, and 21 CFR
Part 11 guidelines*
5. *Hands on experience in using Test management tools like HP ALM/QC*
6. *Experience in working in Global Delivery model*
7. *Good co-ordination skills*
* ROLES AND RESPONSIBILITIES* :-
1. *Author, review and manage validation team and validation
deliverables: *
1. *Project Plan *
2. *Contribution to Data Privacy Plan *
3. *Contribution to FRS, Requirement Analysis *
4. *Contribution to Integrated Risk Assessment *
5. *Identification Of Supporting System Documentation (ISSD) *
6. *Validation Plan *
7. *Test Plan *
2. *Designing and reviewing SOPs/Work instructions*
*Review and approve all documentation and deliverables*
*SHARE ME THE DETAILS ATTACHING YOUR PHOTO ID ASAP *
Candidate Name:
Contact Number:
Email ID:
Work Status:
Current location:
Willing to relocate:
Expected Salary:
Relevant Experience:
Overall Experience:
Available Time:
Notice Period:
*--*
Vicky Kumar* | Technical Recruiter*
*IT–SCIENT LLC, Fremont, CA, USA*
*ll IT-SCIENT - Talent Management Group ll*
*ll Phone USA : (510) 516-7899 ll Fax: 877.701.4872*
*EMAIL : vi...@itscient.com
<vi...@itscient.com> // vicky.kumaritsci...@gmail.com
<vicky.kumaritsci...@gmail.com>*
*Web: www.itscient.com <http://www.itscient.com/> *
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