Computer System Validation Specialist

Company: Alpha Consulting ( Learn More )

General Information
Not Specified
Not Specified
Not Specified

Required Skills and Experience (5+ years)
  • Performance of Gap, Risk, and 21 CFR Part 11 Assessments
  • Technical writing (Validation Plans, Requirement Specifications, Test Plans and Scripts, Summary Reports, SOPs, Technical Service Manuals, Retirement Plans)
  • Ability to develop and execute strategies for the remediation of compliance gaps
  • Detail and process oriented
  • System Retirement documentation and procedures
  • Data and records archiving
  • Excellent technical writing, document review, and editing skills (spelling, grammar, communication).
  • Strong presentation skills
  • Must be a "self-starter able to take the initiative to develop project deliverables and work plans as necessary with minimal supervision
  • Strong business and process understanding
  • Strong interpersonal skills and ability to create strong working relationships
  • Must be able to manage work on multiple projects concurrently
  • Must have the ability to work collaboratively as a member of a team and be comfortable with "role flexibility , i.e., sometimes being the team leader and sometimes being a subordinate
  • Must be tolerant, understanding, and adapt easily to ongoing changes in a fast-paced, evolving environment with integration challenges similar to the acquisition of one firm by another
  • Technical understanding of computerized systems including virtualized, externally hosted, and SaaS:
  • The validation implications of the technology and the manner in which it is used
  • Comprehensive understanding of what can go wrong
  • Ability to ask probing questions to facilitate the assessment of comprehensive risk, including 21 CFR Part 11 and gaps (i.e., leaving no stone unturned)
  • Utilizes a proactive, consultative approach to assignments, i.e., actively contributes to process, quality, and cost improvements
  • Politely but firmly tracks down required information.
  • Commitment to consistently producing quality work products.

  • Tools Experience:
  • Microsoft Office Suite
  • Microsoft SharePoint

  • This 8+ month position starts ASAP.

    Please E-MAIL your resume (attachment to email) with rate and availability to Cheryl: [Click Here to Email Your Resumé]

    REQUIREMENT #17-00415
    W2 ONLY
    Job Requirements