ROLE AND RESPONSIBILITIES
Reporting to the Projects and Compliance Supervisor, the incumbent coordinates certain projects and the activities pertaining to the branch's regulatory compliance. Specifically, he/she ensures compliance of services regarding process changes that impact controlled documents and validation of the manufacturing equipment and processes.
Your primary mandate is to be actively involved in the process for obtaining and maintaining the various certifications required for the Human Tissue Use Branch (e.g. AATB, Health Canada).
Specifically, when a project is being set up, you:
• Coordinate the various project-related activities such as: change control management, assessment of the impacts on processes, the writing of controlled documents, validation, space re-fitting, implementation planning, etc.;
• Cooperate with stakeholders from the other branches for applying the processes and implementing the regulatory aspects.
Also, when work processes or methods are changed, you:
• Check the impacts on existing controlled documents and make appropriate modifications while coordinating those changes in keeping with the time lines and other organizational branches affected;
• Are actively involved with the management team in establishing corrective (or preventive) actions further to the identification of actual (or potential) problems and check their impact on controlled documents;
• Plan and coordinate the annual SMP review and identify information, while being closely involved in drafting the Quality Review;
• Do various follow-ups with suppliers in connection with product changes (software, equipment, reagents, services, etc.);
• Prepare and do follow-up for internal and external audits;
• Increase your knowledge of the applicable regulations;
• Are involved in maintaining compliance of the branch's activities with the regulatory standards;
• Are involved in preparing the certification submission package.
• University degree in science or other field deemed relevant;
• At least 3 years of experience in a regulated environment, especially in terms of regulatory compliance;
• Experience in the pharmaceutical field is considered a major asset;
• Good writing skills;
• Proficient using the programs in the Microsoft Office suite;
• Fluent in French and English, both oral and written.
• Strong communication skills and be known for building good interpersonal relationships;
• Good ability to analyze and synthesize;
• Excellent organizational, planning and priority management skills, and able to take the lead on multiple matters;
• Strong teamwork skills and a good team player who is focused on respect and collaboration;
• Demonstrate independence, vitality and thoroughness in managing mandates.
In addition to the competitive working conditions offered by Héma-Québec, this position includes the following benefits:
• Daily work schedule of 35 hours per week;
• Four weeks of vacation per year;
• Flexible schedule;
• Group insurance;
• Defined benefit pension plan.