Your Role
* Perform control and release activities for products and active principles manufactured at the Evionnaz site, under your responsibility.
* Ensure that all major deviations and out-of-specification results (OOS) are thoroughly investigated and closed.
* Approve changes with an impact on product quality.
* Review production/finishing files and analytical data before releasing finished products for sale.
* Evaluate and participate in the management of non-conforming lots in production.
* Participate in client audits and official organizations (FDA, Swiss Medic, etc.) and internal audits.
* Write annual production reviews, plans, and procedure validations.
* Notify clients within the context of Quality Agreements.
* Approve master Production and Analytical documents (MBR, monographs…).
* Participate in the company's ongoing GMP training.
Your Profile
* Bachelor or Master's degree in chemistry.
* Experience in a similar position.
* Knowledge in a GMP environment.
* Ability to make decisions, rigor, and analytical sense.
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