Design Responsible

Fresenius Kabi AB · Full-time

Rapsgatan 7, Uppsala, Sweden

We are a growing company with approximately 1,000 employees in Sweden and over 40,000 employees worldwide. Our pride in our products permeates the entire company. In our employee surveys, colleagues, development opportunities, and a family-like atmosphere are highlighted as some of the best things about working at Fresenius Kabi. Being part of Fresenius Kabi is synonymous with being part of an environment with future prospects. We believe in our employees and are passionate about developing all our staff members. You have great opportunities to influence how that development looks. Fresenius Kabi has also, for the fourth year in a row, been designated as a Career Company and thus an attractive employer in Sweden thanks to our unique career opportunities. Our global organization means there is a great variety of paths to choose from as part of your future development. 1 position(s). Operations Sweden is in an expansive phase where several products are being transferred to our site in Uppsala from Fresenius Kabi's R&D centers and factories in other parts of the world. Do you have a strong interest in product quality in Life Science and want to contribute to the development of life-saving medicines? Then this could be the right role for you. Responsibilities We are looking for a Design Responsible with responsibility for finished products for the Tech Transfer & Product Lifecycle Management department. You are responsible for the regulatory documentation of products, product validation, and manufacturing methods and specifications. You also contribute to ensuring deliveries in our ongoing tech transfer projects. A large part of the position involves close collaboration with colleagues at Fresenius Kabi, nationally and internationally, where your contribution is crucial to the high quality of our products. Participate in projects for new products and changes related to existing products Responsibility for product validation Responsibility for specifications and manufacturing methods Issue, review, and maintain registration documentation within Chemistry, Manufacturing and Controls (CMC) Respond to questions from authorities regarding the product during inspections and on submitted external documents Act as an expert in investigations of major deviations and changes Responsibility for stability studies and monitoring of relevant product trends Coordination to ensure that requirements in external documentation are followed internally About You We are looking for someone who is self-driven, analytical, and structured. You should be quality-conscious and thorough in your work and be comfortable working in a rapidly developing operation. We see that you are highly communicative and collaborate well with internal and external contacts. We are looking for someone who has: Academic education in chemistry, pharmacy, or equivalent, such as a degree in chemical engineering or pharmacy At least five years of experience from the pharmaceutical industry Experience with CMC documentation Very good ability to communicate in Swedish and English, both orally and in writing About the Position The position is a fixed-term employment on probation which, after 6 months, will transition to permanent employment by agreement between the parties. Start date immediately. Contact If you would like to know more about the position, you are welcome to contact recruiting manager Johanna Lindh via e-mail [email protected]. For trade union contact persons, you can email [email protected] to contact Unionen and [email protected] to contact Akademikerföreningen. We warmly welcome your application via the link. We unfortunately do not accept applications via e-mail or mail. Selection and interviews take place on an ongoing basis. The position may be filled before the final application deadline, so do not hesitate to submit your application today! Our recruitment process includes tests, interviews, reference checks, and background screening. At the interview, we ask you to present your degree certificate and relevant certificates. For the final candidate, a pre-employment health screening will be conducted by our occupational health service. Employment Type: Permanent. Duration: Permanent.