Contract Validation Specialist

Contract Validation Specialist

02 Mar 2021
New Jersey, Princeton, 08542 Princeton USA

Contract Validation Specialist

Title: Contract Validation Specialist

Location: Princeton, NJ

Duration: 6+ Month contract

About the Company: An American contract research organization providing comprehensive, integrated drug development, laboratory, and lifecycle management services.

Benefits: Real Staffing offers medical, dental, vision, 401K, voluntary life insurance, short term/long term disability.

Your Main Responsibilities:

  • Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes

  • Follow SOPs and industry best practices

  • Possess 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 system

  • Review validation deliverables for projects which are contracted to third party suppliers

  • Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues

  • Assist in planning, implementing, and documenting user acceptance testing

  • Review computerized systems validation documents such as:

    • Requirements Specification

    • Design Specification

    • CSV Risk Assessment

    • Test Plans

    • Test Summary Reports

    • Data Migration Plan

    • Pre/Post Executed Test Scripts

    • Traceability Matrix

    • Release to Production Statements

  • Direct and review testing

  • Provide guidance on quality issues that affect the integrity of the data or the system

  • Obtain and respond to QA review

  • Participate in establishing standard quality and validation practices

  • Independently assess compliance practices and recommend corrective actions

  • Approve validated computer system related change requests

  • Monitor regulatory and inspection trends and advise the business on suitable action

  • Ability 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.

Basic Qualifications:

  • 3-5 years of CSV script and document quality review experience

  • 3 years of HP ALM

  • 3 years of CSV Documentation

  • 2-3 years of experience in Change Control

  • Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g. HP ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc)

Sthree US is acting as an Employment Business in relation to this vacancy.

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Job Details

  • ID
  • State
  • City
  • Job type
  • Salary
    USD $60 - $68 per hour 60 - 68 per hour
  • Hiring Company
    Real Staffing
  • Date
  • Deadline
  • Category

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