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CSV intermediate – computer system validation


This is a Full-time position in Montreal, QC posted January 14, 2020.

Computer System Validation (CSV) Specialist IntermediateUni3t Group is a young and dynamic IT company that is active in life science and pharmaceutical industry.The Uni3T Group was born of a desire to bring together and unify a comprehensive expertise in the field of life sciences under one roof.

Our mission is to improve access to health care and products by providing consulting services and technology solutions to life sciences companies.Our approach is based on three main axes.

All our missions start with obtaining a strategic vision that is highly aligned with the needs of our customers.

We work with customers on transforming their processes to unleash their full organizational potential.

Finally, technologies can be deployed to optimize the Business value chain through the automation of key processes.We are looking for a talent to join our professional services team.

This professional will work directly with our CSV specialists on computerized systems validations (CSV) in a regulated environment.Responsibilities:Perform verifications and reviews of validation documents for systems and processes of our customers.Coordinate CSV projects for software and automated systems.Elaborate validation strategies and plans.Coordinate different stakeholders’ activities (IT department, SMEs, end users, quality unit, vendors).Conduct risk analysis and define qualification process.Write and review risks assessments and applicable test scripts according to GxP and 21 CFR Part 11 compliance guidelines and the Validation procedures.Develop SDLC deliverables, such as: validation plans, requirements, specifications, traceability matrices, test protocols (IQ, OQ and PQs), qualification reports.Execute qualification protocols to ensure compliance and adherence with applicable guidelines.Review and modify Standard Operating Procedures (SOPs).Communicate CSV approaches and requirements during meetings and workshops.Develop and perform customer training.Qualifications and skills required:Fluent in written French and English.Strong communication and interpersonal skills.Interested in making a contribution to the company while learning.

Proactive and organized.Self-starter.Assets/ Good to have:Minimum of 4 years of experience in the life science or pharmaceutical industry.Bachelor Degree in Computer Sciences (Security, Infrastructure, Software), Engineering (Chemical, Biomedical, Biotech, etc.) or Life Science (Biochemistry, Chemistry, Pharmacy, etc.).Perks and Benefits:Competitive base salary + bonus (based on company, team and individual efforts).Comprehensive insurance coverage by Sunlife.Permanent full time position.Located between Griffintown and the Old Montreal, in the Cité du Multimédia neighborhood, now part of Montreal’s holistic hub for innovation, education, and entrepreneurship: Quartier de l’Innovation.What you need to knowMust be legally eligible to work in Canada at the location(s) specified above and, where applicable, must have a valid work permit or study permit that allows the candidate to fulfill the requirements of the role.