Spécialiste, Conformité / Specialist, Compliance

at  Jubilant DraxImage Inc

QUALIFICATIONS :

• Baccalauréat en sciences ou en génie chimique
• Au moins cinq (5) ans d’expérience dans le soutien du système de gestion de la qualité des médicaments et/ou des dispositifs médicaux dans l’industrie pharmaceutique, des dispositifs médicaux ou de la biotechnologie.
• Expérience des inspections de la FDA ou de Santé Canada
• Connaissance approfondie des réglementations GxP pour le Canada, les États-Unis, l’Europe et des normes compendia (USP, Ph.Eur.) ainsi que de la FDA 21 CFR 820 / ISO 13485 / EU MDR
• Capacité à comprendre les questions scientifiques afin d’aider à la planification du travail.
• Connaissances informatiques (Microsoft Office, environnement SAP et eQMS)
• Bilinguisme (français et anglais).

SPECIALIST, COMPLIANCE

Join our dynamic team at Jubilant Radiopharma as Specialist, Compliance! We are seeking a driven individual who thrives in a fast-paced environment and is passionate about ensuring the highest standards of quality and compliance in our operations.

QUALIFICATIONS:

• BSc in Science or Chemical Engineering
• Minimum Five (5) years of experience supporting Drug and/or Medical Device Quality Management System in pharmaceutical, medical device or biotechnology industries
• Experience with FDA or Health Canada inspections
• In-depth knowledge of GxP regulations for Canada, USA, Europe and compendia standards (USP, Ph.Eur.) as well as FDA 21 CFR 820 / ISO 13485 / EU MDR
• Ability to understand scientific issues in order to help the planning of the work
• Computer literacy (Microsoft Office, SAP environment and eQMS)
• Bilingual (French & English).

JOIN US:

If you are looking for a challenging yet rewarding opportunity to make a difference in the healthcare industry, we invite you to apply for the Specialist, Compliance position at Jubilant Radiopharma. Join us in our mission to deliver innovative solutions that enhance patient care and improve lives. Apply now and be part of our success story!
Job Overview

ROLE OVERVIEW:

The Compliance Specialist will be responsible for ensuring GxP appropriateness of operations and continuous improvement activities are established, monitored and maintained to ensure compliance with all applicable regulations and procedure at Jubilant Radiopharma.

KEY RESPONSIBILITIES:

• Maintains knowledge and understanding of current industry practices to ensure Subject Matter Experts are aware of industry improvements and compliance risks;
• Acts as Subject Matter Expert for the quality system (CC, CAPA, Investigations (including OOS/OOT), Complaints, extensions etc)
• Conducts gap assessments to assess compliance in regards to HC, FDA, ISO, ICH, and regulations impacting cGMP/ ISO operations, as well as for updates in new Regulatory requirements;
• Analyzes key performance indicators of the quality system to highlight areas of improvement;
• Prepares and completes Annual Product Quality Reviews by adhering to the established schedule;
• Oversees and follows-up the CAPA, CC, Investigation and Complaint systems with regards to timelines and closures.
• Supports compliance continuous improvement projects (based on trends, internal audit observations, etc.) that can be leveraged across departments, functions, and product families.
• Participates in Internal Audits and Site Inspection activities (preparation, readiness and execution);
• Performs additional duties as assigned by reporting manager.