Spécialiste, Audit de conformité / Specialist, Compliance Audit

at  Jubilant DraxImage Inc

QUALIFICATIONS:

• Minimum BSc en chimie, biochimie, microbiologie ou dans une discipline scientifique connexe.
• Le titre d’auditeur qualité certifié est un atout, mais n’est pas exigé.
• Cinq (5) à dix (10) ans d’expérience dans un environnement réglementé par le GXP, y compris des audits internes et des audits de fournisseurs.
• Vaste expérience des systèmes de qualité pharmaceutiques.
• Expérience avec les autorités réglementaires et les dispositifs médicaux, y compris le processus de certification ISO 13485 / MDSAP.
• Connaissance approfondie des réglementations GXP pour le Canada, les États-Unis et l’Europe.
• Connaissances informatiques (Microsoft Office, SAP, TrackWise et ComplianceWire).
• Bilingue (français et anglais) avec une bonne maîtrise de l’anglais parlé et écrit.
• Solides compétences en matière de relations interpersonnelles et de communication, ainsi que de solides capacités de rédaction de rapports.

QUALIFICATIONS:

• Minimum BSc in chemistry, biochemistry, microbiology, or related science discipline.
• Certified Quality Auditor is an asset, but not required.
• Five (5) to ten (10) years of experience in a GXP regulated environment, including internal and supplier audits.
• Broad experience in pharmaceutical quality systems.
• Experience with regulatory authorities and medical devices, including ISO 13485 / MDSAP certification process.
• In-depth knowledge of GXP regulations for Canada, US, and Europe.
• Computer literacy (Microsoft Office, SAP, TrackWise, and ComplianceWire).
• Bilingual (French & English) with proficiency in spoken and written English.
• Strong interpersonal and communication skills, along with solid report writing ability.
  Join Us:
  If you’re ready to take the next step in your career and make a meaningful impact in the pharmaceutical industry, we invite you to apply for the Compliance Auditor position at Jubilant DraxImage. Join us in our mission to deliver quality healthcare solutions and shape the future of medicine. Apply now and be part of our innovative team!
  Job Overview

• Develop, maintain, and execute internal and supplier audit programs, ensuring compliance with GMP regulations and contractual agreements.
• Conduct supplier audits to guarantee adherence to Jubilant DraxImage requirements and regulatory standards, and prepare comprehensive audit reports for management review.
• Track and trend audit observations and CAPAs, ensuring timely completion.
• Manage Supplier Quality Agreements and Supplier Corrective Action Requests (SCARs).
• Translate regulatory requirements into quality systems and communicate them effectively to relevant personnel.
• Assist site operations during regulatory inspections and participate in associated tasks.
• Maintain records related to auditing in compliance with retention schedules.
• Proactively review observations from regulatory inspections to identify potential risks for the company.
• Perform additional tasks as assigned by management.