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Quality Assurance Specialist, Quality Notifications

ProMetic Sciences de la Vie inc.

This is a Full-time position in Laval, QC posted October 1, 2018.

CONTRACT : 12 MONTHS

 

At Prometic, over 450 people work at saving lives, one role at a time. Located at the heart of the Cité de la Biotech in Laval, our Prometic Bioproduction Inc. division is blooming as we are currently developing a treatment for orphan diseases affecting children, made of plasma-derived proteins. Our treatment will allow these children to have a new pathway to hope.

To contribute to this revolutionary and innovative project, we are looking for a Quality Assurance Specialist, who will be in charge of managing all aspects of quality notifications, in line with the Quality Management System, to ensure an exemplary compliance level in an FDA-approval context.

The Quality Assurance Specialist will contribute to the team by:

  • Coordinating, reviewing and approving incident reports, deviations, investigations, as well as issue and process CAPAs;
  • Managing all quality notifications within the electronic Quality Management System;
  • Performing trending on various quality systems and writing appropriate reports;
  • Maintaining the filing of all paper copies as well as tracking logs pertaining to quality notifications;
  • Processing product complaints and writing internal investigations to address these;
  • Conducting in-house audits of cGMP compliance;
  • Participating in the authoring and review of SOPs.

You are the right person for this role because:

  • You hold a bachelor’s degree (BAC) in Chemistry, Biochemistry, Biology or Pharmacy;
  • You have at least 4 years of experience in a similar role and you therefore demonstrate a high problem-solving ability for complex issues;
  • You have an exhaustive understating of GMP regulations and requirements, in Canadian, American and European contexts;
  • You are not intimidated by an environment with frequent priority shifts and aim at using your know-how and confidence to bring structure;
  • You write English in an impeccable manner;
  • You successfully use a collaborative approach.

Prometic offers you:

  • A fantastic team who strives at doing things in the best possible way;
  • A casual environment;
  • A « start-up » culture that values autonomy, innovation and collaboration;
  • A competitive salary and benefit package, which includes participation in shareholding program;
  • A unique opportunity to change lives through your commitment and contribution.

 

 

Send us your resume right away to: hr@prometic.com with the reference PBP-QA-1805.

The usual fine lines:

Prometic is an equal opportunity employer. For more information about Prometic, visit our website www.prometic.com.

Skills Required

  • Education level: None
  • Work experience (years): None

Package

Salary: N/D

How to Apply