Global Computer Validation Specialist

Hands on position responsible for authoring test scripts and other
CSV documents required for the validation of GAMP 5 Category 4
(configurable off the shelf) computer systems. Candidates should be
familiar with COTS systems used for clinical development and quality
activities in a pharmaceutical environment. Work with business users
and Information Technology to ensure the systems remain in a validated
state through appropriate change control procedures. May require
participation in early morning and/or evening teleconferences with
global project teams.

1. Create
   and/or review computer system validation test scripts, validation
   schedules, risk assessments, requirement specifications, protocols and
   reports, traceability matrices, and validation summary reports according
   to the timelines in the project plan. Review applicable procedures and
   system training manuals as applicable. Participate in project team
   meeting. (85%)
2. Document
   requirements for business requirements, system security, user roles,
   workflows, data flows, GxP requirements and how these systems fit into
   the larger IT infrastructure. (10%)
3. Work
   with IT and User Groups to: (a) evaluate change control requests, (b)
   assess regulatory risk associated with such requests and (c) determine
   the corresponding validation requirements for such changes. (5%)

• 2 – 3 years experience writing CSV test scripts, protocols and summary reports in global environments
• Bachelors or Masters in Computer Science, Computer Information Systems, Information Technology or related discipline.

Knowledge and skills (general and technical):

• Sufficiently
  knowledgeable of FDA/EU/MHLW Regulatory Requirements and industry best
  practices for computerized system validation to complete tasks
• Experience working with global teams particularly with team members from Japan
• Understands lifecycle approach as well as risk based approach to validation
• Generally familiar with GXP regulations particularly in the GCP and Quality areas
• Able to work both independently and as a member of a cross-functional project team
• Good written and oral communication skills
• Good problem solving skills
• Microsoft products such as Word, Excel, Project, and Visio.
• Familiar
  with Information Technology principles, functionalities and
  capabilities of computer systems; and how computer systems relate to and
  integrate with larger corporate IT infrastructures

$40/hr

6 MONTHS +