Your role
* Réaliser les activités de contrôle et de libération des produits et principes actifs fabriqués sur le Site d’Evionnaz dont il a la responsabilité.
* S’assurer que toutes les déviations majeures et les résultats hors spécifications (OOS) sont dûment investigués et clôturés.
* Approuver les changements ayant un impact sur la qualité du produit.
* Assurer la revue des dossiers de production / finition ainsi que les données analytiques avant la libération des produits finis pour la vente.
* Évaluer et participer à la gestion des lots non-conformes en production.
* Participer aux audits clients et des organismes officiels (FDA, Swiss Medic, etc.) ainsi qu'aux audits internes.
* Rédiger les revues annuelles de production, les plans et les validations de procédés.
* Avertir les clients dans le cadre des Quality Agreements.
* Approuver les documents master de Production et Analytique (MBR, monographies…).
* Participer à la formation continue GMP de l’entreprise.
Your profile
* Titulaire d'un Bachelor ou Master en chimie.
* Expérience dans une position similaire.
* Connaissance du milieu GMP.
* Capacité à prendre des décisions, rigueur, et sens de l'analyse.
Working at Siegfried
Siegfried's work environment is dynamic and international. With a highly professional and motivated team, the company operates in a future-oriented business field. Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places the highest priority on providing a flexible, diverse, and discrimination-free working environment where employees can develop personally and professionally, advance innovation, and deliver superior performance. We strive to provide a work environment where employees can take on challenging jobs and responsibilities that serve their personal and technical development and benefit from the success of our company. The company regulations regarding compensation and career development opportunities apply to all Siegfried sites. Additional employment conditions are governed by location-specific circumstances, legislation, and customs.
Who we are
In the Midst of People’s Lives – Across the Globe The Siegfried Group is one of the world’s leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates, and finished dosage forms. We successfully integrate chemical and pharmaceutical capabilities into a single business model. The Siegfried name stands for highest quality, efficiency, flexibility, and safety. Present in Europe, Asia, and North America, we serve a broad global customer base, from major international pharmaceutical companies to small biologic-pharmaceutical organizations. We develop and produce product innovations on a large scale to finished products, integrating our offer seamlessly into the customers’ value chain. Our services range from early-stage Research & Development, such as synthesis, scale-up, formulation development, stability studies, and method development, to manufacturing services, including preclinical R&D material for clinical trials and commercial production. We produce about 200 of the approximately 1500 registered drug substances used in medicine and 20 percent of global demand for caffeine, impacting nearly 1 billion individuals.
What we do in Evionnaz
Siegfried Evionnaz is a facility specialized in custom synthesis of active ingredients and intermediates for the pharmaceutical industry. The chemicals plant, built in 1957, employs around 350 people across various fields, including production, laboratories, logistics, quality assurance, and administration.
Main activities
* Development and production in strict compliance with quality standards (GMPs).
* Ensuring perfect compliance with safety, health protection, and environmental standards.
Unique features
* 6 GMP production units (315 m³) with reactors from 0.5 to 8 m³.
* 2 Pilot and Kilolab installations with reactors of up to 1,000 liters.
* Flexible, multi-product production lines.
* Broad portfolio of technologies: azide chemistry, organometallics, cryogenics, phosgenation, and more.
Strategic impact
* Facility highly specialized in niche technologies.
* Development capacity: from 1 gram to industrial quantities.
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