💡 Recomiendo: Echa un vistazo también a ofertas de trabajo similares entre las que seguramente encontrarás algo que te interese.
Quality Assurance External Sites Specialist
Responder al anuncio Fecha: 2 sept. 2024
Ubicación: SAB0 - PHARMA SANT ANDREU DE L
Misión
Ensure GxP compliance in subcontracted manufacturers management of the Almirall group's pharmaceutical products.
Funciones y responsabilidades
New business and cross functional projects
- Integration and maintenance of CMO portfolio in ALM IT systems; Trackwise SQM, Official List & SKUs
- Participation in cross functional teams and projects of CMO products
- Data collection for Risk assessment of products and CMOs
- Execution of assigned activities/projects for the defined Annual plans
- Ensure implementation of KPIs
- Identify and propose improvement actions in CM QMS
- Review and maintenance of CM QMS SOPs
- Maintenance of QA agreements
- Follow-up of implementation of CAPAs from audits and inspections
- Participation in GMP audits
- Identify, propose and execute improvement actions in CMO performance
- Record and follow-up of quality events: change control, OOS, deviations and CAPAs
- Collection of PQRs from CMOs
- PQRs initial validation and submit for approval (eDMS)
- Follow-up of specific plans related to implementation of new regulations
- QA Support to regular supply and market disposition when applicable.
- Ensure fluent and effective communication with internal and external stakeholders
Formación
Education: Bachelor Degree in Life science (Pharmacy, Chemistry, Biological sciences or similar subject)
Conocimientos específicos
Good knowledge and skills in the use of advanced personal computer programs and systems such as Trackwise and eDMS.
Ability to influence and collaborate with others, negotiation and proactivity.
Languages: Advanced written and verbal communication skills in Spanish and English.
Travelling and moving availability.
Experiencia
2/3 years experience in GMP fabrication environment and contract manufacturers management
Valores
- Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
- Courage: we challenge the status quo, we take full ownership and we learn from our success & failures
- Innovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.
- Simplicity: we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.
¡Sea el primero en responder a este anuncio de trabajo!
-
¿Por qué está buscando trabajo en Trabajas.es?
Crear alerta de empleo
Cada día nuevos anuncios de trabajo Puede elegir entre una amplia gama de trabajos: nuestro objetivo es ofrecer una selección lo más amplia posible Déjenos enviar nuevos anuncios por correo electrónico Sea el primero en responder a las nuevas ofertas de empleo Todos los anuncios de trabajos en un único lugar (de empleadores, agencias y otros portales) Todos los servicios para demandantes de empleo son gratuitos Le ayudaremos a encontrar un nuevo empleo