Computer System Validation Specialist

Imeka is a technology platform company that has brain imaging based translational biomarkers for: neuroinflammation, demyelination, and axonal loss. These biomarkers are useful for pharmaceutical and biopharmaceutical companies that develop treatments for neurodegenerative diseases such as: Alzheimer’s and Parkinson’s diseases, as well as Multiple Sclerosis. Imeka is currently the only company in the world combining diffusion MRI and AI to map white matter integrity in the brain.

  • Our vision is a world in which everyone can thrive and grow old with their full brain capabilities;
  • Our mission is to offer the best brain imaging tools and services to help those who are developing treatments and cures improving brain health;
  • We value curiosity, kindness, dynamism, trust and contributing to science;
  • We pursue our vision and mission with great passion and we are looking for someone to join us in pursuing our goals.

Position Overview

Reporting to the technology lead, the hire will take care of documenting the various levels of specifications surrounding computer system validation, as well as managing the test strategy, develop and execute the test scripts.

In this role, you will be responsible to:

  • Plan the work to be done and ensure that deadlines are met in collaboration with validation, including hardware and software, to support enterprise systems that impact GxP;
  • Write computer system validation plans and reports;
  • Write and review of deliverable validation products, including URS, FS, IQ, OQ, PQ, etc.;
  • Write test cases and prepare test data;
  • Correct discrepancies associated with computer system validation for impact and resolution;
  • Write reports to summarize the results of computer system validation activities;
  • Assess system changes using a risk-based approach and assign the appropriate level of validation requirements;
  • Perform risk assessment activities;
  • Manage data integrity in accordance with various regulations in force (FDA, 21CFR Part 11, etc.);
  • Ensure compliance is established and maintained at all times;
  • Write and maintain operating procedures and/or computer validation policies as required;
  • Keep abreast of industry guidelines and regulations;
  • Work closely with quality manager and development team.

Qualifications:

  • Bachelor’s degree required, preferably in health or computer sciences;
  • A minimum 5 years of experience directly in or in a role affiliated to the life sciences industry, with a minimum of 3 years of experience in Computer System Validation;
  • A proven knowledge of the validation processes of computer systems using the guidelines ISPE GAMP5;
  • Must be familiar with a GxP environment;
  • Strong knowledge of GxP and QMS principles;
  • Profound knowledge of software testing strategies and can apply them;
  • Experience/knowledge of systems such as Office suite and JIRA/Confluence is an asset;
  • Strong knowledge of Health Canada, FDA regulations;
  • Ability to build and maintain respectful and trusting relationships with all internal and external stakeholders at all levels;
  • Ability to work effectively independently and as a team;
  • Strong reporting skill to various user levels;
  • Ability to prioritize work and switch between different tasks and projects seamlessly;
  • A strong attention to detail, and ability for problem solving and root causeidentification;
  • You can negotiate with internal staff, subcontractors, consultants and suppliers to ensure that GxP-sensitive systems are implemented and remain in a validated state;
  • Excellent written and oral communication skills, in both French and English.

What we can offer:

  • Full time position
  • Competitive salary
  • Good healthcare plan
  • Fast growing business in a fast growing market
  • Flexible schedule
  • Dynamic team

Other useful information:

Location: Sherbrooke

Send your cv and your motivation letter to [email protected] before July 19th, 2021.

IMPORTANT – Make sure to include, in the subject line of the email: “Application for the Computer System Validation Specialist position”.

*Please note that only candidates selected for an interview will be contacted.

Looking forward to meeting you!

Imeka is truly a great place to work.

But why?

  • Exceptional synergy – Have you ever heard of a 0% turnover rate?
  • Steady growth in the last 8 years – More and more exciting projects
  • Meaningful work – That plays a part in a thriving economy, in our community and around the world
  • Cool people – Not just cool as in hip, but as in caring, motivated and motivating
  • A management model that fosters productivity and satisfaction in equal measures – Not what you are used to in typical corporate environments
  • Geared towards giving – This applies to giving to employees, giving the best to our clients and giving back to our community (1% of company time is spent towards community work)