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QA/Business Analyst - Clinical Data Systems

Toronto, Ontario
Flex People Solutions is currently searching for a contract QA/Business Analyst on behalf of a client of ours in the clinical data management business located in Toronto. Our client is a well established leader in this field and is in a growth mode looking to add to the team.

This position is a fulltime 10 month contract and is located in the West End of Toronto (Islington/401 area).

Position Overview.

The QA/Business Analyst is a key member of the Custom Software Development (CSD) team and is responsible for the planning, coordination, oversight and documentation of the software development and validation efforts.
Key Responsibilities
  • Works with System Owner, Subject Matter Specialists, and Developer to generate system requirements (business – functional – design) for new requirements, changes and fixes;
  • Oversees the change management process, issue management;
    Responsible for development and maintenance of the validation documents such as test plans, test cases / scripts, traceability matrix and reports as per defined validation approach, including change management using a Web-based app. (qTest);
  • Responsible for setting up test system environments, test data, and train and coordinate project team members for execution of test scripts;
  • Schedules and oversees test execution, documentation and reporting;
  • Maintains validation documentation inventory and test library;
  • Works with Technical Writer to development User Guides and other technical documentation.
  • College diploma or Bachelor degree preferably in Computer Science, IT, Health Informatics or related technical field;
  • In-depth knowledge and documented experience in using various software validation methodologies (SDLC, agile development);
  • Minimum 3 years experience in software quality assurance role or validation;
  • Experience writing test cases
  • 1-3 years programming experience;
  • Knowledgeable of regulatory compliance requirements in the pharmaceutical industry (GXPs), particularly those related to validation, electronic records and electronic signatures;
  • Excellent oral communication skills, and strong technical writing skills including the ability to produce clear, concise documentation;
  • Self-motivated, with the ability to learn quickly and independently, and work within a team;
  • Demonstrated ability to problem solve.
  • Validation experience or work experience in a regulated (FDA / GxP) company;
  • Experience with Domino/Lotus Notes environment;
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