Please submit resumes to sriram@saperedata.com
-- Title: Validation Lead
Location : Vernon Hills, IL
Location : Vernon Hills, IL
Duration: 6+ months
Client: CSC
H1b copy is a must.
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"
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.
b. 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.
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"
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.
b. 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 |
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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