*Greetings !!! *

This is Pavan Kaparthi, Sr. Technical Recruiter from AVANI TECH SOLUTIONS
INC.  We have an Immediate Closable Requirement with one of our client.
Please find the below Position and share me if you have any suitable
consultants resumes to *pava...@avanitechsolutions.com
<pava...@avanitechsolutions.com>*



*Position : Validation Lead*

*Location : Vernon Hills, IL*

*Duration : 6+ Months*



*Job Description : *



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

·         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

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

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

·         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.

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

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

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

·         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.

o   Contributes to or gathers CSV metrics for reporting purposes.

·         Coordinate and execute protocols

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

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

·         Coaches third party testers on good testing and documentation
practices.



*Desired skills / certifications / training *

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

·         Strong knowledge of project development/implementation processes.

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

·         Experience using Quality Center.

·         Ability to make goo d judgments and quick decisions.

·         Solid presentation skills.

·         Solid oral and written communication skills and teamwork skills.



*-------------------------------*

*Pavan Kaparthi*

 pava...@avanitechsolutions.com |
http://in.linkedin.com/pub/pavan-kaparthi/54/2b2/b36/

​​ ​585-351-2945  585-285-4133

 www.avanitechsolutions.com

722 Weiland Rd, Suite # 205, Rochester, NY 14626

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