Validation Specialist – Senior
Townsend & Associates | Pennington , NJ | Posted : 10/3/2014
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JOB DESCRIPTION


Validation Specialist – Senior

 

Responsibilities:

 

  • The Validation Specialist – Senior must apply FDA, MHRA, and other applicable global regulations to the development of computer systems supporting regulated business processes

  • The Validation Specialist – Senior will follow SOPs and industry best practices

  • The Validation Specialist – Senior will conduct training on good documentation and good testing practices

  • The Validation Specialist – Senior will facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system

  • The Validation Specialist – Senior will review validation deliverables for projects which are contracted to third party suppliers

  • The Validation Specialist – Senior will 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

  • The Validation Specialist – Senior will assist in planning, implementing, and documenting user acceptance testing

  • The Validation Specialist – Senior will 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

  • The Validation Specialist – Senior will direct and review testing

  • The Validation Specialist – Senior will provide guidance on quality issues that affect the integrity of the data or the system

  • The Validation Specialist – Senior will prepare validation summary and test summary reports

  • The Validation Specialist – Senior will obtain and respond to QA review

  • The Validation Specialist – Senior will participate in establishing standard quality and validation practices

  • The Validation Specialist – Senior will independently assess compliance practices and recommend corrective actions

  • The Validation Specialist – Senior will approve validated computer system related change requests

  • The Validation Specialist – Senior will monitor regulatory and inspection trends and advise the business on suitable action


JOB REQUIREMENTS


                                                             Validation Specialist – Senior 


W2 ONLY!!! NO CORPS TO CORP.



Qualifications:

 

  • 6+ years experience required for the Validation Specialist – Senior

  • Advanced knowledge of complete MS Office suite and Visio required for the Validation Specialist – Senior

  • Firm understanding of technology platforms as needed for project is necessary for the Validation Specialist – Senior

  • The Validation Specialist – Senior must have the ability to create documents to an existing document standard.

  • The Validation Specialist – Senior must have a working knowledge of Documentum.

  • Excellent oral and written communication skills in English a requirement for the Validation Specialist – Senior

  • Strong expertise and ability to interview and accurately interpret communication requirements of team members is a necessary skill for the Validation Specialist – Senior

  • The Validation Specialist – Senior  must be able to develop all documentation required for a 21/11 validated project, including Validation Plans and Summaries

  • The Validation Specialist – Senior must have experience in producing software documentation and business requirement documentation (minimum 3 yrs)

  • The Validation Specialist – Senior must have experience with Software Development Life Cycle Management and CFR 21 Part 11 compliance




JOB SNAPSHOT

Employment Type: Contractor
Base Pay: N/A
Other Pay: Competitive salary based on experience
Industry: Pharmaceutical
Biotechnology
Other Great Industries
Education: Not Specified
Experience: 6 to 9 years
Manages Others: Not Specified
Relocation: No
Required Travel: Not Specified
Job ID: 14-01452
COMPANY OVERVIEW
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Townsend & Associates, Inc.

Our Vision

Townsend & Associates, Inc. provides cutting edge staffing solutions to Fortune 500 companies. Our belief is understanding the culture and needs of our client and matching that criteria with the perfect candidate, thus establishing Townsend & Associates, Inc. as the staffing firm both clients and professionals turn to first.

Our Value

Since our inception, we have been passionate, motivated, and committed to providing the best overall experience to our clients.

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  • Validation Specialist – Senior @ Townsend & Associates