Spécialiste Sénior, Conformité / Senior Specialist, Compliance

at  Jubilant DraxImage Inc

QUALIFICATIONS :

• Baccalauréat en sciences ou en génie chimique
• Au moins sept (7) ans d’expérience dans la gestion d’un système 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
• Maîtrise de Microsoft Office, de l’environnement SAP et de l’eQMS.
• Bilingue (français et anglais) à l’écrit et à l’oral

SENIOR SPECIALIST, COMPLIANCE

Join our dynamic team at Jubilant Radiopharma as Senior 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:

• Bachelor degree in Science or Chemical Engineering
• Minimum seven (7) 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
• Proficient with Microsoft Office, SAP environment and eQMS
• Bilingual (French & English) both written and spoken

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 Senior 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 Senior Compliance Specialist will be responsible for ensuring cGMP appropriateness of operations and continuous improvement activities are established, monitored and maintained to ensure compliance with all applicable regulations and procedures.

KEY RESPONSIBILITIES:

• Acts as a lead resource and SME in the team and supports team members in Compliance activities; delegate to Compliance Supervisor;
• Supports Site Compliance Inspection Readiness activities and continuous improvement projects (based on trends, internal audit observations, etc.) that can be leveraged across departments, functions, and product families.
• Maintains a good knowledge and understanding of current industry practices to ensure Subject Matter Experts are aware of industry improvements and compliance risks;
• Conducts gap assessments to assess compliance in regards to HC, FDA, ISO, ICH, EU MDR and regulations impacting cGMP/ ISO operations, as well as for updates in new Regulatory requirements;
• Analyzes key performance indicators to highlight areas of improvement;
• Ensures that the reporting manager is aware of the improvement requirements and builds an integrated plan that delivers both the needed results and the growth in capability (skills and culture) for sustaining Continuous Improvement;
• Reviews and assesses Supplier change notifications for supplied products (ex: raw material, packaging material etc.)
• Reviews and assesses supplier qualification in CC, CAPAs and Investigations.
• Supports Internal Audits and Quality Agreements, if needed;
• Maintains the supplier quality management program
• Maintains the quality system (CC, CAPA, investigation, complaints, OOS etc) to meet KPIs and metrics
• Participates in the maintenance of the Annual Product Quality System (writing and adherence to established schedule);
• Meets global KPIs and metrics;
• Performs additional duties as assigned by reporting manager