Qualification / Validation Expert - 1 Jahr befristet

Poste

Temps plein

Durée déterminée

Senior

Santé

Modalités

Basel

Clôture dans 30 jours

Exigences

5+ ans d'exp.

Bachelor

Permis UE/AELE

Compétences

Learning Management SystemAseptic processingCAPA managementSterilization validationVeevaeVALMESSAPChange ManagementGood Manufacturing Practice (GMP)Risk ManagementPharmaceutical development

Langues

Allemand C1

Anglais C1

Description

Das Clinical Manufacturing Network (PTDN) stellt bahnbrechende Therapien aus den klinischen Phasen her, um Patienten in aller Welt zu versorgen - und dies jeden Tag. Unser Kerngeschäft ist die Produktion sicherer, innovativer und wirksamer Arzneimittel, wobei hochmoderne Technologien in Herstellungsverfahren für Wirkstoffe und Arzneimittel zum Einsatz kommen. Innerhalb unserer Sektion Science & Technology streben wir nach prozesstechnologischer Exzellenz, um höchste Qualität und regulatorische Compliance im Drug Product Clinical Supply Center (Parenterals) in Basel zu gewährleisten. Gemeinsam zeichnen wir uns verantwortlich für die Herstellung und Abfüllung von sterilen Darreichungsformen aus dem globalen Forschungs- und Entwicklungsportfolio. Für die Belieferung klinischer Studien der Phasen I–III stehen zukunftsorientierte Fertigungsanlagen in einem modernen Gebäude zur Verfügung. Wir streben eine fürsorgliche und empathische Netzwerkorganisation an, die eine Kultur des Vertrauens und der Zusammenarbeit lebt. Unsere engagierten Mitarbeitenden treiben Innovationen durch ihr Fachwissen, ihre Leidenschaft und ihre "Get-it-done"-Mentalität voran. Dabei steht der Nutzen für den Patienten im Mittelpunkt unserer Überlegungen und Bemühungen.

Responsabilités

Independent and responsible management of all process engineering aspects of facilities and equipment for the production and filling of parenterals as a subject matter expert (SME)
Creation of concepts and rationales to ensure the qualified or validated status of our manufacturing, cleaning, and sterilization processes according to applicable guidelines and regulatory requirements
Planning and execution of qualifications & validations in the aseptic working environment including documentation according to Good Documentation Practices
Coordination and execution of process engineering changes and optimizations in collaboration with internal partners and external service providers
Ownership of simple to complex deviation, change, and CAPA records including root cause analyses
Leading investigations and troubleshooting of equipment issues and participating in process-related deviations in manufacturing
Representation of the area in local and global committees, inspections, and audits, as well as active support of complex local and global projects

Exigences

Completed scientific/technical degree (e.g. pharmaceutical engineering, chemistry/pharmacy, process/chemical engineering, biotechnology) or vocational training in the pharmaceutical field with several years of relevant professional experience and at least 5 years of experience in a GMP-regulated environment
In-depth knowledge of production processes, pharmaceutical or process engineering with technical understanding and interest in complex, highly automated systems
Good knowledge of leading GMP regulations (e.g. EMA, FDA, and PIC/S Guidelines)
Strong sense of responsibility, precise working method, and reliability even under time pressure
Ability to apply standard office programs and production-supporting IT systems
Negotiation-level German and English skills in spoken and written

Technologies

VeevaeVALSAPMESLearning Management System

Avantages

A diverse and international working environment with various development opportunities
A culture of trust and collaboration
Encouragement of personal expression and open dialogue

Entreprise

Roche

Pharmaceuticals

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.