Quality Systems Specialist, Systèmes Qualité

This is a fully remote position, open to applicants in Canada.

📋 Description

• Ensure the maintenance of a compliant quality management system.

• Conduct audits in line with the predefined audit program.

• Plan, execute, and document audit reports.

• Provide observations and recommendations, and review responses along with CAPA plans.

• Monitor CAPA plans until they are fully resolved.

• Assess quality-system nonconformities and track trends and progress regarding CAPA closures.

• Participate in activities related to quality indicators.

• Advise on quality-system matters and take part in initiatives for process improvement.

• Assist in creating training materials concerning quality systems and GxP topics.

• Deliver training sessions to Indero employees.

• Fulfill client-requested RFIs.

• Support client qualification audits and regulatory inspections, including mock inspections.

• Aid in the development and revision of quality documents.

• Undertake additional responsibilities as qualified, experienced, or adequately trained.

⛳️ Requirements

• Bachelor’s degree in a relevant field or equivalent experience.

• At least 3-5 years of experience in quality assurance within the pharmaceutical sector or clinical research.

• Strong understanding of ICH guidelines and relevant regulations (Health Canada, FDA, EU).

• Proficient in both oral and written communication.

• Solid knowledge of good clinical practices and applicable GxP regulations.

• Familiarity with GMP is an asset.

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).

• Knowledge of artificial intelligence applications is a plus (e.g., Copilot).

• Excellent organizational skills with the ability to thrive in a fast-paced environment.

• Bilingual proficiency in French and English, both written and spoken.

• Willingness to travel 10-20% of the time.

• Experience in clinical quality and dermatology/rheumatology is advantageous.

• Indero only considers applicants who hold a valid work permit for Canada.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Comprehensive benefits package (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities).

• Opportunities for ongoing learning and development.

• Horaire de travail flexible.

• Poste permanent à temps plein.

• Avantages sociaux complets (soins médicaux, soins dentaires, soins de la vue, REER, vacances, jours personnels, clinique médicale virtuelle, rabais sur le transport en commun, activités sociales).

• Formation et perfectionnement continu.