Business Systems Analyst With Gxp/Validation

Business Systems Analyst

Remote work within Canada

Duration: 6 months with extension

Hours: 40 hours per week

PAY RATE: $40/hr CAD plus GST/HST if Incorporated

:

• Good understanding of requirement gathering methodologies, for example waterfall, Agile, Spiral, JAD sessions, as well as best practices
• Good understanding of system development life cycle and requirements methodology especially within global life sciences regulation
• Write Performance Qualification (PQ) tests with little to no knowledge of an application by working with the technical SME(s), business owner and other project team members
• Know when Objective Evidence is required for a PQ test.
• Ability to write use cases
• Address PQ test incidents, ensure traceability matrix is accurate, and validation summary report is valid.
• Helps to define interaction of data with other systems/databases at PPD or client companies.
• Good MS Office skills
• Ability to write specifications for moderately complex systems
• Formulates and defines systems scope and objectives through research and fact finding combined with an understanding of applicable business systems and industry requirements.
• Good understanding of different requirement types such as Business, User, Functional, and non-Functional and able to elicit and document these requirements from technical and non-technical people.
• Analyzes business and user needs, documents requirements, and designs the functional specifications for systems and reports.

Required Skills:

• Normally receives general instructions on routine work, detailed instructions on new projects or assignments.Exercises judgment within defined procedures and practices to determine appropriate action.
• Strong planning and organizational skills
• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• 2+ years’ experience working in a software development environment, of which at least 2 years must be directly involved in requirement gathering)
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.Ability to perform under stress.Ability to multi-task.
• Hours vary based on project deliverables.May be early in the morning or later at night.
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.Requires multiple periods of intense concentration.
• Ability to interact with relational databases at an intermediate level
• Strong problem solving and analytical skills
• Must have atleast 5 years of experience with GxP / Validation.
• Ability to estimate level of effort for small to large sized projects
• Good business skills including the following: documentation, presentation, interpersonal, and communication