Quality Assurance Specialist

Detalles de la oferta

Job DescriptionJoin our team at our company, where we are committed to delivering innovative health solutions that advance the prevention and treatment of diseases in people and animals. As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality of our vaccine manufacturing process. This is an exciting opportunity to contribute to our mission of using leading-edge science to save and improve lives around the world.ResponsibilitiesEnsure compliance with the Quality Systems in the vaccine manufacturing process.Ensure compliance with GMP regulations, our company's Quality Manual, and regulatory requirements.Review batch documentation of products manufactured by our company.Perform the pre-UD (UD, Usage Decision) process for the release of products manufactured by our company to the market.Support adherence to the product release plan manufactured by our company.Manage Quality information and metrics.Manage Quality Assurance (QA) documentation.Create and maintain Quality master data in SAP.Manage specifications.Review and implement regulatory changes.Quality member in product complaints.Preparation and review of PQR (Product Quality Review).Creation, review, and approval of deviations, CAPAs, and change controls.Support as QA representative in the introduction or transfer of new products.Support as QA representative in process validation.Perform Quality Oversight.Preparation, review, and approval of risk analysis.Participation in external and internal audits.Participation in continuous improvement projects.QualificationsUniversity education in Health Sciences.Relevant professional experience in the pharmaceutical sector (at least three years).Advanced English.Advanced knowledge of GMP regulations and regulatory requirements.Demonstrated ability to analyze, solve problems, and communicate effectively (oral/written) in Spanish and English.Experience in Quality Assurance (QA).Knowledge of batch documentation review and approval processes by Quality.Knowledge of product release processes by Quality.Knowledge of Quality System tools: change controls, deviation management, out-of-specification results, CAPAs, claims.Data management in SAP.Demonstrable experience in participation in projects, transfers, and audits.PreferredKnowledge of manufacturing processes, equipment, and facilities in the pharmaceutical sector, especially in the manufacturing processes of biological and sterile products.Knowledge of Quality Control (QC) tests.Experience in risk management, statistical tools, and continuous improvement methodologies.
#J-18808-Ljbffr


Salario Nominal: A convenir

Fuente: Whatjobs_Ppc

Requisitos

Ufs Spain Kar 360O Valladolid Viladecans, Espagne

Location: Valladolid Work Areas: Salamanca/Zamora/Avila/ Segovia ABOUT UNILEVER With 3.4 billion people in over 190 countries using our products every day, U...


Unilever France - Salamanca

Publicado 5 days ago

Técnico /A De Control De Calidad

Desde Eurofirms buscamos un/a técnico/a de control de calidad para una empresa ubicada en Guijuelo. La persona seleccionada realizará las siguientes funcione...


Eurofirms Group Slu - Salamanca

Publicado 5 days ago

Ufs Spain Kar 360O Valladolid Viladecans, Espagne

Location: Valladolid Work Areas : Salamanca/Zamora/Avila/ Segovia ABOUT UNILEVER With 3.4 billion people in over 190 countries using our products every day, ...


Unilever France - Salamanca

Publicado 4 days ago

Ufs Spain Kar 360O Valladolid

UFS SPAIN KAR 360º Valladolid Location: Valladolid Work Areas: Salamanca/Zamora/Avila/Segovia ABOUT UNILEVER With 3.4 billion people in over 190 countries us...


Unilever - Salamanca

Publicado 4 days ago

Built at: 2024-11-22T01:02:44.168Z