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).
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.
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;