Quality Systems Specialist, Systèmes Qualité

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🔥 0 minutes ago

🇨🇦 Canada – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👻 Ghost score 12%

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🗣️🇫🇷 French Required

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Logo of Innovaderm Research Inc.

Innovaderm Research Inc.

201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

💼 Consulting

Pharmaceuticals • Healthcare • Consulting

Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.

📋 Description

• Maintain a compliant quality system • Execute audits in accordance with the established audit program • Plan, conduct, and write audit reports • Issue observations/recommendations and review responses and CAPA plans • Follow up on CAPA plans until closure • Review quality-system nonconformities and track CAPA trends and closure progress • Contribute to quality-indicator activities • Consult on quality-system issues and participate in process-improvement initiatives • Contribute to training content related to quality systems and GxP topics • Provide training to Indero employees • Complete client-requested RFIs • Assist with client qualification audits and regulatory inspections, including mock inspections • Contribute to writing and revising quality documents • Perform additional responsibilities when qualified, experienced, and/or adequately trained

🎯 Requirements

• Bachelor degree in a relevant discipline or equivalent experience • Minimum of 3-5 years’ experience in quality assurance in the pharmaceutical industry or clinical research • Good knowledge of ICH guidelines and applicable regulations (Health Canada, FDA, EU) • Ability to communicate effectively both orally and in writing • Good knowledge of good clinical practices and applicable GxP regulations • Knowledge of GMP (an asset) • Good knowledge of the Microsoft Office Suite (Word, Excel, PowerPoint) • Knowledge of artificial intelligence applications is an asset (e.g., Copilot) • Good organization skills and ability to adapt to a rapidly growing environment • Bilingual: French and English, written and spoken • Willing to travel 10-20% of the time • Experience in clinical quality and dermatology/rheumatology (an asset) • Indero only accepts applicants with a work permit for Canada

🏖️ Benefits

• Flexible work schedule • Permanent full-time position • Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities) • 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

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