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Software Validation Specialist

April 19, 2013

Position Overview

The Software Validation Specialist is key to ensuring that Intelex can provide the documentation and assurances our customers need to validate our software against regulatory and industry best practices. A successful candidate will be someone who is confident in not only working with our customers to assist them in their validation activities, but in working with internal stakeholders to ensure that we develop appropriate policies, documentation and controls necessary to support these activities.

Company Overview

For 20 years, Intelex Technologies has been a global leader in Environmental, Health, Safety, Quality and Business Performance Management software. We enable organizations to ensure the highest standard of health, safety and environmental conditions as well as superior product and service quality by streamlining and integrating business data for our more than 600 clients and 500,000 system users around the world. Intelex continues to earn an array of accolades, having been listed in the Deloitte Technology Fast 500 North America for three consecutive years and included on two exclusive lists of GTA's Best Employers in 2012, the results of which were published in The Globe and Mail and The Toronto Star. Intelex was also named one of Canada's 50 Best Small and Medium Employers in 2012 by AON Hewitt and Queen's School of Business, and ranked 5th in the Great Place to Work Institute's list of 100 of the best places to work in Canada.

Responsibilities and Deliverables

  • Serve as a Subject Matter Expert (SME) in responding to and managing Intelex's response to customer validation activities.
  • Act as an internal Subject Matter Expert (SME) for customer audits and reviews of our processes and related documentation.
  • Collaborate with project teams and customers to develop, design and document: Use Cases, Test Plans, Test Cases, Test Scripts, Traceability Matrices and other documentation needed to support Software Validation activities.
  • Work with Intelex, and project teams to create IQ/OQ/PQ documents as appropriate.
  • Provide strategic and expert technical guidance to sales teams during the sales cycle.

Qualifications

  • Experience with validation, verification, regulatory activities involved with providing software to medical and pharmaceutical industries.
  • Knowledge of 21 CFR Part 11, GAMP 5, GxP, PIC/S Annex 11, CMMI and other regulatory standards, guidelines, and best practices.
  • Strong attention to detail
  • Able to work under pressure and meet aggressive deadlines
  • Effective verbal and written communication skills

Please submit a resume to jobs@intelex.com. It is recommended that you visit the www.intelex.com website prior to submission and have an understanding of our business and business needs prior to interview.

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