*Please submit resumes to sri...@saperedata.com <sri...@saperedata.com>*



*Title: Validation Lead Consultant*

*Location: Vernon Hills, IL*

*Duration: 6+ months*

*No. of positions: 15*



*Client: CSC*



*Job Description :*



1. Responsible for creating, managing the documents required for the
development and validation of the computerized system and infrastructure -
3 to 5 Years

2. Authors/Reviews Validation Plan, Training Plan, Issues Log, Design
Review, Integration Qualification Protocol/Report, Operational
Qualification Protocol/Report, Production Qualification Protocol/Report,
Test Cases, Test Incidents, Trace Matrix, Change Controls and Validation
report. 3 to 5 Years

3. Executes the overall protocol process, including validation document
creation, infrastructure test case creation/review and incident management,
and status reporting. 3 to 5 Years

4. Prepares documentation within a validation package per policy and
procedure to support the validation of enterprise systems and
infrastructure. 3 to 5 Years

5. Coaches third party testers on good testing and documentation practices.
3 to 4 Years



*Optional skills*



This position is responsible for leading and performing activities in
support of the validation and compliance of computer systems and
infrastructure. The Validation Lead is responsible for monitoring
compliance to the CQPs, Baxter QMS, and other established IT
policies/procedures.

1. Leads the Computer Validation activities within a project or multiple
global projects with medium to high complexity.

2. Responsible for creating, managing the documents required for the
development and validation of the computerized system and infrastructure.

a. Create and/or review all validation documents in the project.

i. Authors/Reviews Validation Plan, Training Plan, Issues Log, Design
Review, IQ Protocol/Report, OQ Protocol/Report, PQ Protocol/Report, Test
Cases, Test Incidents, Trace Matrix, Change Controls and Validation report.

ii. Reviews and updates/signs off on Functional Specifications,
Design/Configuration Specifications, System Description and Training
records.

a. Contributes to or gathers CSV metrics for reporting purposes.

3. Coordinate and execute protocols

a. Executes the overall protocol process, including validation document
creation, infrastructure test case creation/review and incident management,
and status reporting.

4. Prepares documentation within a validation package per policy and
procedure to support the validation of enterprise systems and
infrastructure.

5. Coaches third party testers on good testing and documentation practices.
Desired skills / certifications / training

1. Minimum of 5 years experience in Computer Systems or Software Validation
including infrastructure.

2. Strong knowledge of project development/implementation processes.

3. Experience validating enterprise and quality systems like ArisG,
Trackwise, Documentum, ERP, LIMS including infrastructure set up and
qualification.

4. Experience using Quality Center.

5. Ability to make good judgments and quick decisions.

6. Solid presentation skills.

7. Solid oral and written communication skills and teamwork skills.



*Thanks & Regards*



*Sriram,*

*Saperedata Technologies | A Pool of Wise Professional*

*sri...@saperedata.com <sri...@saperedata.com>*

*Direct: 732-429-1833*

*Desk:7325268688 Ext:  106*

*1433 Oak Tree Road, Level 2*

*Iselin, NJ 08830*

*Fax #201-508-2996*



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