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CSV Validation _ Dallas, TX at Dallas, Texas, USA
Email: [email protected]
Greetings,

We have the below requirement with our client. Kindly go through the JD below and let me know your interest

Role name: Engineer

Dallas, TX

Duration : Contract

Role Description:

CSV, Validation, Testing, Reports, Test, data validation, GAMP, CFR

Competencies: EIS : Medical Device & Regulations

Experience (Years): 4-
6

Essential Skills
:

Computer System Validation Engineer

Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV)
guidance.

Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles.

Compliance Analysis, Validation Planning, Risk Assessments

Test planning and strategy

creation and execution of test protocols, scripts and reports.

Validation Summary Reports, traceability analysis.

Defect Logging and Tracking till closure.

Desirable Skills:

Role

Computer System Validation Engineer

Responsibilities-

Develop, approve, and execute validation deliverables for computerized systems, including validation plans, risk assessments, and traceability matrices.

Author and update documentation to support ongoing CSV compliance.

. Prepare or review all levels of validation documents including:

o Validation (Strategy) Plans, User Requirement Specificationso Definition Documents, including Functional Specifications S/W Design Specifications or Configuration Documents and SOPs

o Qualification Documents and Test Specifications (IQ, OQ, PQ)

o Traceability Matrices, Risk Analysiso Validation Reports, Change Controls/ Events / Deviations etc

Assess the impact of changes proposed to computerized systems and the level of change required.

Provide validation strategy to the introduction of computerized systems.

Collaborate with the key stakeholders (Information Systems, Software assurance, business users and suppliers etc) and management on all related matters on a regular basis.

Submission Format:

Full Name

Mobile and Home Phone No

Email ID

US work authorization/ Visa validity

Current Location

Willing to Relocate / Travel (Yes/No)

Currently on a project

Interview Time slots

Availability for Project

Expertise & Skills Sets

Total Relevant Experience

Education & University Name

 & Specialization

Prior work experience with TCS (Y/N)

If Yes -  BA ID & Employer Name while working with TCS

LinkedIn id

Rate

Best Regards,

Jessica(Bhargavi Jalthar)
|Sr Technical Recruiter| Email: [email protected]

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Keywords: business analyst information technology golang Idaho Texas
CSV Validation _ Dallas, TX
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Thu Dec 12 23:41:00 UTC 2024

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