Job Details

ID #17313637
State New Jersey
City Princeton
Job type Contract
Salary USD Negotiable Negotiable
Source TSR Consulting Services, Inc.
Showed 2021-07-26
Date 2021-07-25
Deadline 2021-09-23
Category Et cetera
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CSV Specialist/ Computer System Validation Specialist- W2 only

New Jersey, Princeton, 08540 Princeton USA

Vacancy expired!

TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence. Our client, a leading Pharmaceutical company is hiring a Validation Specialist on a long-term Contract basis.Rate type: W2 only The candidate must be able to work onsite once the WFH policy is lifted, so local is preferred. Those not local will be considered if they are willing to relocate at their own expense.Must Haves: 5+ years of experience in managing the projects as CSV specialist /lead 5+ years of experience in testing , (script reviewing from a QA perspective in particular ) 5+ years of experience in authoring , reviewing various validation documentation such as (Val plan , Risk assessments etc) Good communication and writing skills Data Integrity experience is a plus6+ years experienceApply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processesFollow SOPs and industry best practicesPossess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer systemReview validation deliverables for projects which are contracted to third party suppliersMaintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issuesAssist in planning, implementing, and documenting user acceptance testingReview computerized systems validation documents such as:Requirements SpecificationDesign SpecificationCSV Risk AssessmentTest PlansTest Summary ReportsData Migration PlanPre/Post Executed Test ScriptsTraceability MatrixRelease to Production StatementsDirect and review testingProvide guidance on quality issues that affect the integrity of the data or the systemObtain and respond to QA reviewParticipate in establishing standard quality and validation practicesIndependently assess compliance practices and recommend corrective actionsApprove validated computer system related change requestsMonitor regulatory and inspection trends and advise the business on suitable actionAbility to create documents to an existing document standard.Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g. Client ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc)Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.Once trained, have the ability to work independently on CSV projects with minimal oversight.Ability to perform in a highly matrixed organization structureSincerely yours, Thank you, Nitin Patel Technical Recruiter TSR Consulting Services, Inc. 379 Thornall Street, 6th Floor, Edison, NJ 08837 Email: Office:

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