*Dear Recruiters,*

*Let me know if you have any consultants for Validation Leads.*

*REQUIREMENT:*

*Job Title: Validation Leads*

*Location: Baxter Vernon Hills, IL*

*Duration: 6+ months*

*Interview Type: Will hire off phone or Skype.*

*The Infrastructure Qualification/Validation Lead will drive the
qualification requirements and execution of multiple
hardware/infrastructure prioritized efforts across Global IT.*

*Purpose of the Position:
**1. Function as Qualification / Validation Lead on multiple assigned
infrastructure projects for hardware refreshes, upgrades, and/or
modifications to infrastructure needed to support quality systems and
applications. Projects may include virtualization, physical moves, and
datacenter qualifications. as well as span global locations.**

Critical Job Responsibilities:
**1. As necessary modify/create Qualification Plan, Protocols, Test Plans,
Risk Assessments, Reports, Trace Matrix commensurate with project
complexity.**
**2. Participate in and guide team in generating/modification Design
Specifications.**
**3. Gain understanding and follow defined SDLC. Ensure quality validation
processes are executed as defined by procedures.**
**4. Develop strategy for the qualification aspects of the project, using
risk-based approach to determine testing, documentation and verification
activities, with appropriate justification of the approach.**
**5. Deploy strategy and documentation requirements.**
**6. Manage electronic routing of required documentation—ensuring
compliance to current procedure for e-approval.**
**7. Communicate status, solutions and concerns. Disseminate information in
a timely manner within the team. Facilitate and address issues within
project.**
**8. Manage qualification testing —coordinating documentation and testing
activities. Generate test scripts, as needed. Execute testing as required.**
**9. Collaborate with vender(s), quality, and technical individuals
throughout project in generation of project / qualification required
deliverables.**
**10. Prepare qualification package for archival.**

Required Qualifications:
**1. Minimum BA / BS or relevant work experience in information systems,
engineering, science or business.**
**2. Highly skilled in Computerized System testing and validation in the
healthcare industry. At least 7-10 years validation experience in both
infrastructure qualification.**
**3. Proven results in managing qualification aspects of infrastructure
project implementation.**
**4. Knowledge of International GxP regulations (e.g. 21 CFR Part 11, 211,
820, PIC/s), as well as Sarbanes-Oxley, HIPAA, and privacy regulations.**
**5. Experience with use/control of Electronic Records/Electronic
Signatures and document management systems, as well as Quality Center--HPQC
for testing.**
**6. Strong technical background—preferably with document management
systems.**
**7. Experience working in a highly regulated environment; GxP, QSR
framework preferred.**
**8. Solid project organizational skills. Ability to multi-task. Must have
strong analytical problem solving skills.**
**9. Excellent communication including written, verbal, and listening
skills.**
**10. Self-motivated, detail oriented, takes initiative and ability to work
independently without close supervision.***


 ------------------------------

*Best Regards*

*Pradeep Bheema*

*Senior Technical Recruiter*

*XT Global (XTG)*

*2701 Dallas Parkway | Suite 550 | Plano, TX 75093*

*Email-ID **[email protected]* <[email protected]>* |Phone:
972-852-2770 | Fax : 888-614-8206 | *

www.xtglobal.com, Inc. 500 Fastest Growing Private Companies in
America<x-msg://449/>

http://in.linkedin.com/pub/pradeep-bheema/19/584/468**

*Certified Minority Business Enterprise (MBE)*

*Oracle Gold Partners*

*Microsoft Gold Certified*

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