Coordinator, Projects and Compliance

March 6 2019
Industries Pharmaceutical, Biotechnology
Categories Project Management, Business Analysis, Pharma, Biotech, Sciences, R&D, Pharma - Biotech, R&D - Scientific, Scientific and Regulatory affairs, Quality assurance and control - Validation, Project management, Production and planning management, Operations (manufacturing, packaging)
Saint-Laurent, QC

ROLE AND RESPONSIBILITIES

Reporting to the Manager, Projects and Compliance, you coordinate projects and all activities related to good manufacturing practices. Based on the quality indicators, you ensure service compliance when changes are made to processes and equipment. You participate in drafting and tracking changes to all regulatory documents, as well as assessing the impacts on validation, work methods and risks related to changes. You are also involved in the investigation process when quality issues arise, as well as in process improvement.

More specifically, you:

  • Plan together with the various managers and act as a resource for the various activities related to project implementation. Ensure the smooth progress of production steps with all stakeholders;
  • Coordinate various projects and committees for labile blood products;
  • Ensure compliance with controlled documents and recommend any necessary changes;
  • Participate in drafting and tracking changes of all regulatory documents related to labile blood products;
  • Assess impacts on operations, validation, controlled documentation and equipment during a change in process; 
  • Assess employee training needs related to process changes in collaboration with operations managers;
  • Are responsible for the implementation and follow-up of recommendations from various regulatory agencies or quality and standards;
  • Track non-compliance and rejections related to sampling; participate in the development of statistics, suggest corrective and preventive measures to operations managers and verify impacts on controlled documentation;
  • Participate in the internal and external audit process; prepare and monitor audits and assist operations managers in drafting audit responses;
  • Plan, coordinate and participate in drafting the quality review;
  • Act as a resource for the management team, as well as collection staff;
  • Perform any other duties related to the nature of the job.

REQUIREMENTS

  • College diploma or university degree in science, or any other relevant diploma;
  • Minimum of 3 years experience in a regulated environment, particularly in regulatory compliance;
  • Familiarity with GMP/GTP and a quality system;
  • Experience in the pharmaceutical field will be considered an important asset;
  • Proficiency in the following Microsoft Office software: Excel, Word and PowerPoint;
  • Functional knowledge of English is considered an asset.

Additional information

Available to travel to the various Héma-Québec facilities, GLOBULE Blood Donor Centres and PLASMAVIE Plasma Donor Lounges

Apply now!

Jobs.ca network

#