Description

"Expect to grow", personal y profesionalmente: En Siegfried, ofrecemos desafíos emocionantes y amplias oportunidades para demostrar tu talento. Como socio de confianza y respeto en la industria farmacéutica, mantenemos los más altos estándares en seguridad, calidad y sostenibilidad, mientras fomentamos una cultura que te empodera para prosperar. Únete a una empresa global en rápida expansión, donde diversas perspectivas y experiencias se unen en un entorno colaborativo. Aquí encontrarás un lugar de trabajo que valora tanto el éxito colectivo como tus contribuciones individuales, ofreciendo oportunidades a largo plazo para crecer y generar un impacto.Your Role: We at Siegfried are looking for a QA Compliance Specialist to join our Quality department at the Masnou site on a 12-month fixed-term contract. Your main responsibilities will be as follows: -Manage the activities of QA oversight for Engineering, Automation, Validation and IT. -Manage the activities of Change Control, Risk Assessment and Computerized System Validation (CSV). -Manage the activities of QA oversight for Data Integrity (DI) in order to maintain and increase DI culture at the site. -Ensure the continuous maintenance and update of the Quality Management System, managing and implementing EU and FDA regulations, ISO standards, internal and external applicable regulations. -Lead Internal Audit Plan and/or take part of the Internal Auditor Team of the site. QA oversight: -Maintain an effective support and oversight for IT, Automation, Engineering and Validation activities related to Quality Systems processes (not wise-batch related), ensuring compliance with the applicable regulations, local and global procedures. -Review and approve (re)qualification and periodic review of processes, systems and equipment. -Ensure effective QA oversight for New or Program Projects as a Project Team Member. For instance, but not limited: review and approve documentation related to process validation, deviations, change control, … -Ensure QA oversight of Pest Control. Data Integrity -Continuously improve Data Integrity knowledge and understanding at the site, act as SME for all DI-related inquiries. -Ensure site support for DI topics during investigations and audits/inspections. -Perform and lead DI Plan, including DI communication and engagement. Report status on a periodic basis to Quality Review Board. Quality Systems: -Ensure governance and compliance of the quality systems as Change Control and Risk Assessment, where appropriate, including appropriate handling with Customers. -Local Key User for Trackwise (support to end users, manage new accesses, perform user periodic review, assessment of system changes) when appropriate. -Coordinate and perform the Quality Management System review through monthly Quality Review Board. -Coordinate and perform KPIs reporting on a monthly basis from the site to Corporate. -Ensure external regulations, standards and applicable guidelines are implemented locally on time. Evaluate new regulation and support SME to document implementation. -Deal with external auditors/inspectors when necessary (Customers, Corporate, Health Authorities). -Ensures the continuous review and update of the Quality systems documents: Quality Manual, Site Master File (Memoria Técnica), Medical Devices File (DMF), Control Contamination Strategy (CCS). -Create, coordinate and ensure continuous review of Quality Plan execution at the site. - Coordinate the Quality Manual implementation with all GxP documentation issued by Corporate. Internal Audits -Set up an effective and efficient Internal Audit Program and ensure its implementation on time. Gives support to the Internal Auditors Team by preparing audit dossier, follow-up of audits, gives orientation and consistent criteria. Miscellaneous : -Ensure the continuous review and update of procedures applicable to his/her activities. -Ensure an adequate regulatory compliance. -Act as a QA approver or coordinator of Change Control/Event/Deviation in TW when applicable. -Take part of the Internal Auditor Team of the site when applicable. -Maintain a high level of scientific knowledge referent to pharmaceutical quality field, ensuring an adequate training. -Develop annual or exceptionally established objectives, ensuring their alignment with Siegfried ones. -Contribute to create a motivating work environment that promotes dedication and professional excellence of the whole team.Your Profile:Requirements: Education: University degree in Sciences.Languages: Fluent in English and Spanish (Catalan is a plus).Experience: 1 to 5 years of progressive experience in Quality Assurance and/or in a sterile manufacturing facility within the pharmaceutical industry. Familiarity with quality systems and production processes (GMP, GLP, FDA, ISO).Your Benefits: We offer:<ul><li>Working hours: Flexible schedule with start time between 7:30 and 9:30 a.m. and finish time between 4:00 and 6:00 p.m.</li><li>Private health insurance</li><li>Life and accident insurance</li><li>Subsidized canteen</li><li>Pension plan</li></ul>Fundada en 1873 en Zofingen, Suiza, Siegfried se ha convertido en una red global con 13 centros en tres continentes. Con un equipo de más de 3,800 profesionales altamente capacitados, llevamos las innovaciones de nuestros clientes farmacéuticos a escala industrial y fabricamos medicamentos seguros para pacientes de todo el mundo. Como CDMO totalmente integrada, Siegfried es una de las pocas organizaciones que actualmente puede llevar a cabo el desarrollo y la fabricación de ingredientes farmacéuticos activos (APIs) y formas farmacéuticas terminadas bajo un mismo techo. Esta combinación única de conocimientos y experiencia nos convierte en el socio más confiable de la industria farmacéutica.