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Computer system validation (csv) specialist – junior

Uni3T

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

Computer System Validation (CSV) Specialist JuniorUni3t 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 young professional will work directly with our senior CSV specialists and will be able to learn computerized systems validations (CSV) in a regulated environment.Responsibilities:Write Validation Protocols such as IQ, OQ and PQs.Execute Validation Protocols such as IQ, OQ and PQs to ensure compliance and adherence with applicable guidelines.Excel Spreadsheet Generation and Summary Report Writing for PQ studies.Review and modify Standard Operating Procedures (SOPs).Generate test procedures to validate new or previously unvalidated processes.Write risks assessments and applicable test scripts according to GxP and 21 CFR Part 11 compliance guidelines and the Validation procedures.Prepare validation summary reports for executed protocols.Communicate Computer System Validation approaches and requirements during planning workshops.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 1 year 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.