Computer Systems Validation Analyst
at Townsend & Associates

Date Posted: 7/19/2018

Job Description

Computer Systems Validation Analyst

Responsibilities:
  • Take direction from a Team Leader to support and enhance the quality and compliance operations posture for an IT department.
  • Author solution development lifecycle documents (SDLC) including user requirements specifications, detailed design and configuration specifications, test plan, test cases, test strategy, change control, and decommissioning plans.
  • Assist in continuous quality systems improvement for this local IT department that interfaces between a set of local site pharma/device manufacturing quality standards and a set of global IT quality standards.
  • Work on operations support (User Account Reviews, Periodic System Reviews, Change Controls) and projects support for these types of systems: laboratory, manufacturing, environmental, quality support, configuration management.
  • Provide technical and compliance expertise to write SDLC documentation in accordance with local procedures, templates, regulatory requirements (21 CFR Part 11, 211, 820), and IT Security Standards.
  • Track and execute computer system Periodic Reviews, User Account Reviews, and other computer system compliance processes as assigned.
  • Provide technical and compliance expertise to support the continuous improvement of BT Departmental operating procedures and processes.
  • Assist in performing change control impact assessments and work with technical subject matter experts.
  • Represent the company IT in site level change control meetings.

Job Requirements

  • Bachelor's degree in Computer Science, Information Technology or other science-related discipline.
  • 3+ years of experience in pharma/device or other regulated industry.
  • Excellent knowledge in writing Validation Documents (e.g. Validation Master Plans, Validation Protocols, Associated SOPs, Part 11 Risk Assessments, Verification Plans, Test Scripts).
  • Must have demonstrated capability in completing projects according to prescribed timelines and other requirements in previous project management or business analyst roles.
  • Familiarity with lab systems, plant manufacturing systems, Document Management Systems, CAPA processes, Learning Management Systems, highly desirable.
  • Be able to function in multidisciplinary teams, must possess excellent documentation, presentation, training and computer skills.
  • Experience with SDLC and other IT project management methodologies; Agile development is a plus.
  • Lean Six Sigma certification and/or experience preferred.



Ref No.:  18-01195

Job Snapshot

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