Validation Software Facilitator

Illinois  ‐ Onsite
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Keywords

Description

Support IT systems by providing software quality assurance services for regulated and non-regulated computerized systems. Assure systems adhere to quality standards and applicable regulations throughout the Computerized System Life Cycle (SLC).

RESPONSIBILITIES:
Specific tasks include but not limited to:
  • Validation Master Planning for IT Systems
  • SLC Review board sponsorship
  • SLC deliverable review and approval
  • Requirements/traceability verification
  • Certification Summaries
  • IT System Production Incident Reports
  • IT System Exception Report support
  • Policy/procedural changes and approvals, as appropriate
  • Audit/inspection support
  • Periodic reviews
  • IT Supplier/Service Provider Evaluation review and approval
  • GPO Library Administration
  • Corporate/Divisional Compliance Plan implementation and support.
  • Responsible for all software quality assurance activities such as evaluation of software life cycle deliverables for compliance with Operating Procedures, FDA requirements and the CFR including 21 CFR Part 11.
  • Lead or participate in various reviews, risk analyses and other software quality assurance activities.

SKILLS:

  • Minimum Bachelor's degree, Have a background in software engineering, software life cycle activities, or software validation and be familiar with the work products that result from SLC key activities.
  • Must be hands-on and professional
  • Knowledge or experience in requirements gathering, analysis techniques, software verification/validation techniques, configuration management techniques or documentation standards.
  • Should be familiar with IEEE, SEI, ISO and have experience in a regulated environment.
  • Analytical skills are important, as is the ability to manage tasks. Must be able to manage multiple tasks and resources.
  • Good with verbal and written communication skills.
Start date
n.a
From
Synectics
Published at
16.11.2013
Project ID:
628727
Contract type
Freelance
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