Publié il y a 14 jours
Deviation/CAPA Specialist
@ GRIFOLS, S.A.
Mississauga, Ontario
En bref
Grifols, a global healthcare company, is hiring a Deviation/CAPA Specialist to manage deviation and CAPA processes in its Quality System. The role monitors Canadian, EMA and Grifols regulatory requirements, tracks quality events and KPIs for Plasma Supply Chain areas, and supports audits. The posting states a bachelor's degree in health sciences, a minimum of 2 years of GMP quality experience, and no salary yet (under review).
Responsabilités :
- Gérer et suivre les systèmes de gestion des déviations et des CAPA
- Réaliser des analyses de causes profondes et des actions correctives
- Suivre les changements réglementaires canadiens et EMA
- Compiler et analyser les indicateurs clés de qualité (KPI)
- Soutenir les audits, inspections et évaluations réglementaires
Résumé des exigences :
- Baccalauréat en sciences de la santé, de préférence en pharmacie
- Minimum de 2 ans d'expérience dans les systèmes qualité GMP
- Connaissance des exigences cGMP et de la gestion de la qualité
- Maîtrise des outils informatiques et de la suite MS Office
- Capacité à appliquer et faire respecter les SOP
Outils et compétences
Source et dates
Site carrière / système de candidatures · successfactors
- Date publiée par l’employeur
- 2026-10-25
- Première détection par notre source
- 2026-10-26
- Mise à jour du dossier source
- 2026-10-31
Ces dates décrivent le dossier source, pas une vérification en direct du recrutement. Consultez l’offre originale.
Détails du poste
| Niveau | Débutant |
| Domaine | Assurance qualité |
| Expérience | 2 an(s) et plus |
| Heures par semaine | 40 (estimé) |
| Milieu de travail | Bureau, Usine |
| Position | Surtout assis |
| Exigences physiques | physique faible · ordinateur élevé |
| Langues | English, French |
| Formation | Baccalauréat (exigé) |
| Domaines d’études | Health-related sciences, Pharmacy |
Résumé et détails rédigés par l’IA à partir de l’offre; l’offre de l’employeur fait foi.
GRIFOLS, S.A.
Profil d’entreprise sauvegardé
Renseignements historiques provenant d’un profil The Jobs API sauvegardé (champs LinkedIn/Crunchbase). Ils ne sont pas vérifiés en temps réel; les chiffres peuvent avoir changé. Les valeurs manquantes restent inconnues.
Innovating for patients and society
Description complète de l’entreprise
Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people all over the world. A leader in essential plasma-derived medicines and transfusion medicine, we develop, produce and provide innovative healthcare services and solutions in more than 110 countries. Patient needs and our ever-growing knowledge of many chronic, rare and prevalent diseases, sometimes life-threatening, drive our innovation in plasma-based therapies and other biopharmaceuticals to enhance quality of life. Grifols is focused on treating conditions across a broad range of therapeutic areas: immunology, hepatology and intensive care, pulmonology, hematology, neurology and infectious diseases. With a workforce of over 23,000 employees in more than 30 countries and regions, we are committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership in the industry. Our work has a positive social and economic impact in the countries where we operate, creating jobs and generating wealth. People are at the heart of what we do, and we strive to create an inclusive, diverse, fair and equal society. Maintaining and promoting a workforce that reflects this reality leads to enhanced professional relationships and helps us to give our best to patients, donors and customers. In 2024, Grifols was named one of TIME’s ‘World’s Best Companies’ for the second year in a row, reaffirming our commitment to excellence. We were also recognized by Forbes as one of the "Best Employers for Women 2023," reflecting our dedication to fostering an inclusive and supportive workplace for all. To maintain a positive community and overall respectful communication, please keep our community guidelines in mind.
- Abonnés LinkedIn
- 286 595
- Personnes associées sur LinkedIn
- 13 691
- Bureaux déclarés
- Parc Empresarial Can Sant Joan, Av. de la Generalitat, 152-158, Sant Cugat del Vallès, Barcelona 08174, ES
- Carrer de Palou, 6, Parets del Valles, Catalonia 08150, ES
- Catégories d’activité
- Health Diagnostics
- Health Care
- Biopharma
- Clinical Trials
- Biotechnology
- Life Science
- Medical
- Manufacturing
- Pharmaceutical
- Autres noms enregistrés
- Grifols Egypt for Plasma Derivatives
- GRIFOLS, S.A.
- Grifols
- Spécialités
- Plasmapheresis
- Plasma derived therapies
- Diagnostics
- Intravenous therapies
- Clinical nutrition
- Automate drug compounding
- Drug inventory control
- and Healthcare
- Le profil indique une agence de recrutement
- Non
- Investissement total déclaré
- 0
La devise et la date d’observation ne sont pas fournies; ce n’est ni une valorisation actuelle ni une ronde de financement.
Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people all over the world. A leader in essential plasma-derived medicines and transfusion medicine, we develop, produce and provide innovative healthcare services and solutions in more than 110 countries. Patient needs and our ever-growing knowledge of many chronic, rare and prevalent diseases…
| Champ | Valeur |
|---|---|
| Secteur | Pharmaceutical Manufacturing |
| Taille | 10,001+ employees |
| Siège social | Sant Cugat del Vallès, Barcelona |
| Type d’organisation | Public Company |
| Fondée en | 1909 |
| Spécialités | PlasmapheresisPlasma derived therapiesDiagnosticsIntravenous therapiesClinical nutritionAutomate drug compounding Drug inventory controland Healthcare |
| Offres sur Jobsy | 33 |
| Voir la page |
Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions. |
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. |
Position title: Deviation/CAPA Specialist
Reports to: QMS Manager
Position Summary:
The Deviation/CAPA Specialist is responsible for ensuring that the Quality System remains compliant with applicable regulations and requirements by monitoring regulatory changes and assessing their impact on quality processes and systems. The role oversees deviation and Corrective and Preventive Action (CAPA) management processes, ensuring that quality events are appropriately documented, investigated, and resolved in a timely manner.
The Deviation/CAPA Specialist also supports the monitoring and reporting of key performance indicators (KPIs), drives continuous improvement initiatives, and facilitates the effective investigation, root cause analysis, and resolution of quality issues to maintain compliance and operational excellence.
Position Objective:
The Deviation/CAPA Specialist is responsible for ensuring that the Quality System complies with Canadian regulations, EMA regulations, and Grifols standards. The role requires staying abreast of current and emerging regulatory requirements, assessing their impact on the established Quality System, and supporting the implementation of necessary updates to maintain ongoing compliance and quality standards.
Position Responsibilities:
- Manage and follow up on the approved Deviation Management and CAPA systems, ensuring appropriate stakeholders are engaged in investigations, root cause analysis, corrective actions, preventive actions, and timely closure of quality events.
- Review, track, and maintain deviation and CAPA records to ensure investigations are adequately documented, completed within established timelines, and compliant with applicable regulatory and company requirements.
- Monitor changes to Canadian regulations, EMA regulations, and Grifols standards, assess their potential impact on the Quality System, and support the implementation of required updates to maintain compliance.
- Support the maintenance and continuous improvement of the Quality System by identifying opportunities to enhance processes, procedures, and regulatory compliance.
- Compile, analyze, and report information related to key process indicators (KPIs) established for Plasma Supply Chain areas, ensuring the accuracy and completeness of quality metrics.
- Monitor and trend quality data, deviations, CAPAs, and KPI results to identify recurring issues, emerging risks, and opportunities for process improvement.
- Facilitate and support investigations, root cause analyses, and the development of effective corrective and preventive actions to address quality issues and prevent recurrence.
- Collaborate with cross-functional teams to ensure quality events are appropriately investigated, documented, resolved, and communicated.
- Prepare and maintain documentation, reports, and records related to deviation management, CAPA activities, KPI monitoring, and Quality System compliance.
- Support internal and external audits, inspections, and regulatory assessments by providing quality records, metrics, and evidence of compliance as required.
- Perform other duties and assigned tasks as directed by the direct Manager.
Required Skills, Qualifications and Experience:
- Bachelor ‘s Degree in Health-related Sciences, preferably in Pharmacy.
- Knowledge of Quality Management.
- Knowledge of cGMP requirements preferred.
- Typically requires a minimum of 2 years of related experience in GMP Quality Systems.
- Pharma experienced preferably.
- Proficiency in Computers, MS Office knowledge.
- Organized and able to manage time effectively.
- Ability to work within a highly regulated, labor intensive environment.
- Ability to understand, explain, follow, and enforce SOPs and protocols
- Ability to plan, communicate and execute activities.
- Strong integrity and commitment to quality and compliance.
The salary range for this position is currently being assessed and will be disclosed upon completion of the compensation review process, in accordance with applicable transparency requirements.
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