QA Manager

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 des 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,
• Evalue et participe à la gestion des lots non-conformes en production,
• Participe aux audits clients et des organismes officiels (FDA, Swiss Medic, etc.) et aux audis internes
• Rédiger les revues annuelles de production, les plans et les validations de procédés
• Avertir les clients dans le cadre des Quality Agreements,
• Approuve les documents master de Production et Analytiques (MBR, monographies…),
• Participation à la formation continue GMP de l’entreprise,

Your profile

• Titulaire d'un Bachelor ou Master en chimie
• Expérience dans une position similaire
• Connaissance en 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 highest priority on providing a flexible, diverse and discrimination-free working environment in which 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 associated responsibilities that best serve their personal and technical development and can benefit from the success of our company. The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites. Additional conditions of employment 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. As our core competence, 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 down to small biologic-pharmaceutical organizations. For them we develop and produce product innovations on a large scale to finished products. We integrate our offer seamlessly into the customers’ value chain. Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies and method development all the way through to manufacturing services, ranging from preclinical R&D material for clinical trial purposes to commercial production. We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine. Moreover, we produce 20 percent of global demand for caffeine. Consequently, nearly 1 billion individuals come into contact with Siegfried products.

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 in a wide variety of fields, ranging from production, laboratories and logistics to quality assurance, administration and more.

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