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Alpha Consulting

Validation Specialist

Alpha Consulting, Princeton

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Job Description
VALIDATION SPECIALIST
PRINCETON, NJ
Hybrid 50% Onsite/Remote
Pay range: $79.36 - $81.69/hr.
Must Have List:
4+ years of experience with the following:

  • SAP Validation experience
  • Use of ALM VERA (Testing reviews, Generating reports/matrices etc.)
  • Data Integrity Requirements
  • 21 CFR Part 11 (CSV)

Required Skills:
  • Bachelor's degree preferred or equivalent experience.
  • 4+ years of experience.
  • 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., HP 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 structure.
  • 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.

Project Description:
  • 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.

This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Loren:
ALPHA'S REQUIREMENT #
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
About the company

Alpha Consulting is a leading Information Technology and Pharmaceutical Recruitment Agency. Contact our IT recruiters for more information.

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