*Hello Business Partners,*

Keen Infotek, Inc have an urgent requirement as follows:
Please direct your email to the listed recruiter
We appreciate your assistance.

Email: Thomas  ***** **[email protected]* *****

**PLEASE SEND ME RESUME WITH FOLLOWING DETAILS IN THE SAME EMAIL TO AVOID
DELAY IN SUBMISSION - THANKS IN ADVANCE*

Total IT :
Total US Experience:
Full Name :
Location :
Contact Number :
Email :
Availability :
Rate on C2C/W2/1099 :
Visa Status  :
Updated Resume:
Employer Details:
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*REQUIREMENT DETAILS :-*

TeamCenter/PLM Application Validation Lead

VERNON HILLS , IL

DURATION : 6 MONTHS+

CLIENT : BAXTER

RATE ::: OPEN … GET ME EXACT MATCH

Purpose of the Position:

1.Act as Validation Lead in the Office of Risk & Effectiveness/Quality

   Assurance Risk Management organization for the TeamCenter/PLM

   Application Enhancement Project

*Critical Job Responsibilities:  *

1.Generate Validation Master Plans, Qualification Protocols, Test Plans,
Risk

   Assessments, Reports, Traceability Matrix, as needed.  May participate in


   generating User Requirements, Functional and Design Specifications.

2.Gain understanding and follow defined Software Development Life Cycle

   and company procedures. Ensure quality validation processes are

   executed as defined by processes and procedures.

3.Participate in design meetings, as required, to gain knowledge of project,


   system, customizations configuration to succeed at delivering assigned

   project deliverables.

4.Communicate status, solutions and concerns. Disseminate information in a

   timely manner within the team. Facilitate and address issues within

   project.

5.Train testers on validation process and incident reporting.  Manage

   validation schedule and testing.  Generate test scripts, as needed.

   Execute testing as required.  May coordinate team of testers.

6.Post-execution review of test cases for completeness, accuracy and

   adherence to policies, procedures and defining protocol(s).

7.Assist in creation of and review/approval of Trace Matrix.

8.Overall document management for all validation deliverables including,

   but not limited to:  managing all aspects of validation package contents;


   assisting in the routing/approval process of documents; archiving

   documents.

9.Collaborate with business, quality, and technical individuals throughout

   project in generation of project / validation required deliverables.

 *Specific Qualifications Required (specialized skills, degrees,
certification, etc.)*


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 and application validation.

3.Knowledge of International GxP regulations (e.g. 21 CFR Part 11, 211,

   820, PIC/s), as well as Sarbanes-Oxley, HIPAA, and privacy regulations.

4.Strong technical knowledge—infrastructure and application.  Retrospective

   validation strategy experience, a plus.

5.Experience working in a highly regulated environment; GxP, QSR

   framework preferred.

6.Solid project organizational skills. Ability to multi-task. Must have
strong

   analytical problem solving skills.

7.Excellent communication including written, verbal, and listening skills.

8.Self-motivated, detail oriented, takes initiative and ability to work

   independently without close supervision.

*For consideration, please forward resume in strict confidence to** **
[email protected]** *

*Thanks & Regards*

*Thomas Fedrick
**Recruiting Specialist "IT Services"*

*[image: cid:[email protected]]*

*710 E || Ogden Ave || Suite #110 || Naperville || IL 60563 ||
Ph: 630-225-7137     || Fax: 630-206-0325
*[email protected]  || www.keeninfotek.com
http://www.linkedin.com/in/thomasfedrick


*[image: Standard Business Partner emblem]*

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