Deviation/CAPA Specialist
Mississauga, CA
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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. |
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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. |
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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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Location: NORTH AMERICA : Canada : Mississauga:CAWINNIP - Winnipeg