Spectraforce Technologies Inc.
Raleigh, NC
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Job Description :
Title: Validation Specialist
Location: Tampa, FL 33634
Duration: 4 months
Responsibilities:
6+ years’ experience Apply FDA, MHRA, and other applicable global regulations to the development of computer systems
supporting regulated business processes Follow SOPs and industry best practices
Conduct training on good documentation and good testing practices
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 Plano 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
Prepare validation summary and test summary reports 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

Required Skills:
Advanced knowledge of complete MS Office suite and Visio.
Firm understanding of technology platforms as needed for project.
Ability to create documents to an existing document standard.
Working knowledge of Documentum.
Excellent oral and written communication skills in English.
Strong expertise and ability to interview and accurately interpret communication requirements of team members.
Able to develop all documentation required for a 21/11 validated project, including Validation Plans and Summaries.
Experience in producing software documentation and business requirement documentation (minimum 3 yrs
Experience with Software Development Life Cycle Management and CFR 21 Part 11 compliance.


Client : confidential
             

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