For a biopharmaceutical company based in Visp, our team is looking for a Specialist to strengthen its quality activities in GMP environment.- Contract : Temporary- Start : Beginning of August- Duration : 5 monthsPrimary mission :The Specialist is responsible for the management, and closure of deviations occurring in a GMP environment, particularly within a large-scale mammalian cell culture facility. The Specialist acts as the point of contact and ensures the identification of root causes, the assessment of quality impacts, and the implementation of effective CAPA.- Write, record, track, and close quality deviations. Ensure document compliance throughout the 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 projects.- Contribute to strengthening the quality culture and GMP compliance.Support improvement :- Bachelor s degree in Chemistry, Biotechnology, Life Sciences or equivalent scientific field.- First experience in deviation management and GMP/cGMP within the pharmaceutical, biotechnology, or API industry, highly appreciated.- Knowledge of biotechnological manufacturing processes and 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 international environment.- English: fluent (written and oral), German is a must. jid349d592aen jit0731aen jpiy26aen
Quality Assurance 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.
