For a biopharmaceutical company based in Visp, our team is looking for a D Deviation Specialist For a biopharmaceutical company based in Visp, our team is looking for a Deviations Specialist to strengthen its quality activities in GMP environment. - Contract : Temporary - Start date : Beginning of August - Duration : 5 months Primary mission : The Deviations Specialist is responsible for the management, investigation and closure of deviations occurring in a GMP biopharmaceutical environment, particularly within a large-scale mammalian cell culture facility. He/she acts as the representative of Operations and ensures the identification of root causes, the evaluation of quality impacts, and the implementation of effective CAPA. • Write, record, track, and close quality deviations. • Ensure document compliance throughout the deviation's life cycle. • Ensure compliance with processing and closing times. • Conduct investigations to identify root causes and contributing factors. • Collaborate with business experts (SME) and relevant stakeholders. • Assess the actual or potential impact on products, processes, equipment, or quality systems. • Use structured problem-solving methodologies (root cause analysis, quality risk management tools) • Define and implement corrective and preventive actions. • Establish efficiency criteria and controls. • Monitor the execution of CAPAs to prevent recurring events. • Participate in change and process optimization projects. • Contribute to strengthening the quality culture and GMP compliance. • Support operational improvement initiatives. Profile : • Bachelor's degree in Chemistry, Biotechnology, Life Sciences or equivalent scientific field. • First experience in deviation management and GMP/cGMP environment within the pharmaceutical, biotechnology, or API industry, highly appreciated. • Knowledge of biotechnological manufacturing processes and associated analytical methods. • Experience in root cause analysis, risk management, and Human & Organizational Performance (HOP) approaches is an asset. • Excellent command of English (spoken and written); German is a plus. • Strong writing, analytical and communication skills. • Organized person, rigorous, proactive and solution-oriented, able to work effectively with multidisciplinary teams in a dynamic and regulated environment. • English: fluent (written and oral), German is a must. jid349d592ait jit0731ait jpiy26ait
Deviation Specialist Arbeitgeber: Gi Life Sciences
En tant qu'employeur de choix, notre laboratoire pharmaceutique à Genève offre un environnement de travail dynamique et collaboratif, où l'innovation et l'excellence sont au cœur de nos activités. Nous valorisons le développement professionnel de nos employés en leur offrant des opportunités de formation continue et de croissance au sein de l'entreprise. Rejoindre notre équipe, c'est faire partie d'une culture qui encourage la diversité, le respect et l'engagement envers des pratiques éthiques dans le domaine de la santé.
