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. 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%) 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%) 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 + Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job.