Global Computer Validation Specialist

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.

Education level and/or relevant experience(s): 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

$45/hr 6+ months