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Computer System Validation Specialist

Job Post Index 21E646-Sy##
Location Princeton, NJ
Description: Job Description
  • Guide project teams through validation process, perform regulatory risk assessments, author, review and approve validation documentation, change requests and testing.
  • Work closely with the application test teams to ensure quality of validation deliverables and testing.
  • 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
  • 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 appraised 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
Skills: Qualifications
  • Experience leading CSV efforts and not just testing experience
  • Strong testing experience with broader knowledge of CSV may be considered.
  • Good communication skills
  • 3-5 years of CSV lead experience
  • 3-5 years of HPALM experience
  • 3-5 years of CSV Documentation author and review, approve
  • 1-2 years of experience in Change Control
  • Experience/understanding of Data Integrity concepts
  • 0-2 years of GAMP experience and understands GAMP categories/validation approaches
  • 6+ years’ of relevant experience
  • 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.
  • Advanced knowledge of complete MS Office suite
  • Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.
  • Firm understanding of technology platforms for projects.
  • Experience using 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)
  • Validation experience on systems such as Veeva, CTMS, and Trackwise.
  • Excellent oral and written communication skills
  • Strong expertise and ability to interview and accurately interpret communication requirements of team members.
  • Ability to perform in a highly matrixed organization structure

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