Corporate Gcp/gvp Quality Assurance-r&d Center Sant
hace 4 semanas
Fecha: 2 may. 2024- Ubicación: SFEL - R&D SANT FELIU DE LLOBR**Mission**:
Provide advice, maintenance, oversight, and continuous improvement of the Almirall GCP Quality Management System, ensuring compliance with applicable regulations and guidelines.
**Functions and responsibilities**:
- Establish and maintain a Quality System for Clinical Trial activities, aligning with the relevant departments to ensure compliance with applicable regulations.
- Develop GCP global quality plans, audit plans, and risk mitigation strategies based on risk assessments. Coordinate, document, and follow up on defined audits. Lead, assist or oversight with audit activities as necessary.
- Lead the preparation and management of inspections by Competent Authorities and audits performed by third parties to Almirall.
- Identify and communicate quality and regulatory compliance issues to the relevant management and recommending remediation.
- Participate in Clinical Study Teams and specific Project Teams.
- Select, coordinate, and oversee outsourced QA activities applicable to clinical trials.
- Stay updated with current regulations, standards, and guidance documents. Contribute to technical guidance, leadership, mentoring, and training as a key stakeholder in quality and compliance matters.
**Education**:
- Bachelor’s/Master’s degree in Health Sciences, Biological Sciences, or a related field.
**Experience and requirements**:
- Minimum of 5 years of experience in GCP.
- Knowledge of GVP is a plus.
- Experience in dealing with Health Authority inspections and audits by external parties.
- Willingness to travel up to 15% of the time.
- Fluency in English, both written and spoken, is essential.
- Detail-oriented and analytical mindset with a clear focus on meeting timelines and objectives.
-
Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completoFecha: 2 may Ubicación: SFEL - R&D SANT FELIU DE LLOBRMission:Provide advice, maintenance, oversight, and continuous improvement of the Almirall GCP Quality Management System, ensuring compliance with applicable regulations and guidelines.Functions and responsibilities: Establish and maintain a Quality System for Clinical Trial activities, aligning with the...
-
SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completoMission Provide advice, maintenance, oversight, and continuous improvement of the Almirall GCP Quality Management System, ensuring compliance with applicable regulations and guidelines. Functions and responsibilities Establish and maintain a Quality System for Clinical Trial activities, aligning with the relevant departments to ensure compliance with...
-
SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completoMission Provide advice, maintenance, oversight, and continuous improvement of the Almirall GCP Quality Management System, ensuring compliance with applicable regulations and guidelines. Functions and responsibilities Establish and maintain a Quality System for Clinical Trial activities, aligning with the relevant departments to ensure compliance with...
-
Intern / Becario/a Quality Assurance for Biological
hace 2 meses
Sant Feliu de Llobregat, España Almirall A tiempo completoFecha: 5 abr. 2024- Ubicación: SFEL - R&D SANT FELIU DE LLOBR**Description**: We are seeking a dedicated and enthusiastic trainee to support our Quality Assurance team in the field of biological products. This is an exciting opportunity to gain hands-on experience and develop your skills in a dynamic and fast-paced environment. **Mission**: The trainee...
-
Intern / Becario/a Quality Assurance for Biological
hace 1 semana
Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completoFecha: 5 abr Ubicación: SFEL - R&D SANT FELIU DE LLOBRDescription:We are seeking a dedicated and enthusiastic trainee to support our Quality Assurance team in the field of biological products. This is an exciting opportunity to gain hands-on experience and develop your skills in a dynamic and fast-paced environment.Mission:The trainee collaborates in the...
-
Controller R&d
hace 2 meses
Sant Feliu de Llobregat, España Almirall A tiempo completo**Date**:06-Feb-2023 **Location**: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain **Company**:Almirall **Mission**: Provide financial and business support to the R&D Functional Area with focus on the Business Partnership with Global Clinical Development and Project Management and contribute to the result optimization of the area through closing,...
-
Quality Assurance Consultant
hace 1 semana
Sant Cugat, Barcelona, España Ambit A tiempo completoWe are looking for a " Quality Assurance Consultant (Software as Medical Devices)" to provide services to a multinational pharmaceutical company. TASKS : Work closely with the software engineering team to establish a strong cross-functional relationship with the various teams involved. Manage digital project quality assurance across functions,...
-
Controller R&d
hace 7 días
Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completoDate:06-Feb-2023Location: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - SpainCompany:AlmirallMission:Provide financial and business support to the R&D Functional Area with focus on the Business Partnership with Global Clinical Development and Project Management and contribute to the result optimization of the area through closing, reporting, analysis, procedures...
-
Intern / Becario/a R&d Project, Portfolio and
hace 2 meses
Sant Feliu de Llobregat, España Almirall A tiempo completoFecha: 20 nov. 2023- Ubicación: SFEL - R&D SANT FELIU DE LLOBR**Misión**: **R&D Project,Portfolio and Partnership Excellent Dept is helping Almirall**: - **t**o drive portfolio management across the R&D value chain, ensuring stakeholders have the right information for robust discussions on project and portfolio progression and prioritization, in order to...
-
Director R&d Project Portfolio Manager
hace 4 semanas
Sant Feliu de Llobregat, España Almirall A tiempo completoFecha: 29 may. 2024- Ubicación: SFEL - R&D SANT FELIU DE LLOBR**Mission**: Maximize business value by aligning R&D projects with the company strategy, balancing risks and making the best use of resources. Secure use of project and portfolio management best practices on planning, monitoring, reporting and managing. **Tasks & Responsibilities**: - Support...
-
Director R&d Project Portfolio Manager
hace 2 días
Sant Feliu de Llobregat, España Almirall A tiempo completoFecha: 29 may. 2024- Ubicación: SFEL - R&D SANT FELIU DE LLOBR**Mission**: Maximize business value by aligning R&D projects with the company strategy, balancing risks and making the best use of resources. Secure use of project and portfolio management best practices on planning, monitoring, reporting and managing. **Tasks & Responsibilities**: - Support...
-
Intern / Becario/a R&d Project, Portfolio and
hace 7 días
Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completoFecha: 20 nov Ubicación: SFEL - R&D SANT FELIU DE LLOBRMisión:R&D Project,Portfolio and Partnership Excellent Dept is helping Almirall:to drive portfolio management across the R&D value chain, ensuring stakeholders have the right information for robust discussions on project and portfolio progression and prioritization, in order to maximize the value of...
-
Director R&d Project Portfolio Manager
hace 7 días
Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completoFecha: 29 may Ubicación: SFEL - R&D SANT FELIU DE LLOBRMission:Maximize business value by aligning R&D projects with the company strategy, balancing risks and making the best use of resources. Secure use of project and portfolio management best practices on planning, monitoring, reporting and managing.Tasks & Responsibilities: Support the R&D portfolio...
-
Director R&D Project Portfolio Management
hace 1 semana
Sant Feliu de Llobregat, Barcelona, España Almirall Hermal GmbH A tiempo completoMissionMaximize business value by aligning R&D projects with the company strategy, balancing risks and making the best use of resources. Secure use of project and portfolio management best practices on planning, monitoring, reporting and managing.Tasks & Responsibilities• Support the R&D portfolio strategy and roadmap definition, monitoring, optimization,...
-
Quality Assurance Trainee
hace 3 semanas
Sant Feliu de Llobregat, España Ferrer A tiempo completo**Quienes somos** Desde Ferrer queremos impulsar una nueva forma de hacer negocio y de estar en el mundo. Nuestro propósito es generar un impacto positivo en la sociedad. Nuestro negocio no es un fin en sí mismo, sino un medio para generar cambios sociales sustanciales. Somos activistas 24/7 luchando por un planeta sostenible, por la igualdad de...
-
Statistician R&d
hace 2 meses
Sant Feliu de Llobregat, España Almirall A tiempo completo**Date**:14 Nov 2023 **Location**: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain **Company**:Almirall **Mission**: The Junior Statistician will be responsible of the design and statistics of clinical trials and clinical development projects within Almirall. The Junior Statistician will partner with senior scientists in clinical (Global Development and...
-
Patient Safety Director
hace 3 semanas
Sant Feliu de Llobregat, España Almirall A tiempo completo**Date**:23 Nov 2023 **Location**: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain **Company**:Almirall **Mission**: The director of patient safety at Almirall is accountable for: - Establishing and maintain a Global/Corporate Pharmacovigilance system that protects patients and users of Almirall medical solutions. - Acting as the EU Qualified Person for...
-
Senior Statistician
hace 2 semanas
Sant Feliu de Llobregat, España Almirall A tiempo completoFecha: 15 may. 2024- Ubicación: SFEL - R&D SANT FELIU DE LLOBR**Mission**: The Senior Statistician will be responsible of the design and statistics of clinical trials and clinical development projects within Almirall. The Senior Statistician will partner with senior scientists in clinical (Global Development and Global Medical Affairs), safety, regulatory,...
-
Scientific Project and Alliance Coordinator
hace 2 meses
Sant Feliu de Llobregat, España Almirall A tiempo completoFecha: 31-may-2023- Ubicación: SFEL - R&D SANT FELIU DE LLOBR**Mission**: To ensure efficient and accurate communication of Almirall R&D with internal and external stakeholders including the coordination of AlmirallShare, maintenance of R&D community and access to key R&D services from academic groups. To support the department, overseeing administrative...
-
Statistician R&d
hace 7 días
Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completoDate:14 Nov 2023Location: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - SpainCompany:AlmirallMission:The Junior Statistician will be responsible of the design and statistics of clinical trials and clinical development projects within Almirall. The Junior Statistician will partner with senior scientists in clinical (Global Development and Global Medical Affairs),...