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Jobs or company...
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Computer System Validation Lead / CSV Lead

Salary undisclosed

Apply on

Dice
Original
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Computer System Validation Lead / CSV Lead

REMOTE / Work From Home

Long Term Contract

We are looking for a CSV Lead with GMP experience in creation, review and approval of CSV deliverables for laboratory informatics implementation projects.

Responsibilities

  • Improve the effectiveness and efficiency of the existing CSV delivery model through the creation of various templates, stools, training courses, and the periodic collection of KPI metrics
  • Provide thought leadership for GMP Systems by working across different departments to deliver CSV-related programs, innovations, and communications
  • Contribute to the operational and process improvement initiatives related to Quality and Compliance
  • Apply CSV expertise to make a major contribution to a specific business unit or department
  • Interpret and execute company policies and procedures that typically and recommend modifications to operating policies
  • Develop Validation testing strategy in accordance with Gilead s policy and procedures
  • Work closely with other validation team members to ensure system impact is assessed and mitigation strategy is in place for multiple sites
  • Partner closely with the business to ensure that CSV methodologies are well understood and applied in a manner that will procedure the most value on LIMS projects
  • Learn, become proficient the EDMS (Electronic Data Management System), for document review, approval and ELMS (Electronic Leaning Management System) for documenting and performing assigned training
  • Prepare, revise and obtain approval of the following documents for GMP laboratories related to the LIS systems:
    • Standard Operating Procedures (SOPs)
    • Work Instructions (WIs)
    • Forms
    • User Manuals / User Guides / User References / Quick Reference Guides and Training Material
    • Training Plans
    • Reference Documents
    • Specifications
    • Reports

Experience / Skills

  • Minimum of 10+ years of experience working in CSV field and GMP Pharmaceutical / Biotechnology / Medical Device environment
  • Advanced knowledge and expertise Computer System Validation, FDA, international requirements and Part 11 requirements
  • Computer Systems Validation (CSV) experience writing validation deliverables per GAMP guidelines is required
  • Ability to master technical content through interaction with subject matter experts
  • Laboratory experience as a chemist or microbiologist, et al is preferred
  • Understanding of programming and relational database concepts is required
  • BA/BS degree; e.g. Biology, Chemistry, Computer Science and/or Technology disciplines is preferred
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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