Quality Specialist

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 the family-friendly 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 of our staff members. You have great opportunities to influence how that development looks for you. Fresenius Kabi has also, for the fourth year in a row, been named a Career Company and thus an attractive employer in Sweden thanks to our unique career opportunities. Our global organization means there is a wide variety of paths to choose from as part of your future development. 1 position(s). We at Fresenius Kabi are now seeking a Quality Specialist for the "QA Quality Management Systems" section. This is an opportunity for you if you want to be part of world-class manufacturing and are passionate about quality work. Our two manufacturing sites, PU Uppsala and PU Brunna/Kungsängen, share a common quality system. In this role, you will have a central position in developing and strengthening the quality system, as well as participating in and leading improvement and change initiatives. You will also be part of the rapid and exciting development currently taking place with us through projects involving major investments and new products. We offer an important, varied, and developmental position with high visibility and significant responsibility. Work Tasks As a Quality Specialist, you will become an expert in quality management systems and an important partner to the organization on quality-related matters. You work closely with operations and contribute to ensuring that our processes meet regulatory requirements, standards, and internal guidelines. In this role, you may among other things: Provide QA support to operations in both Uppsala and Brunna in both operational and strategic matters, in both line and project work Take responsibility for implementing new requirements in the local quality management system and drive the further development of the system Participate in and contribute to customer audits and regulatory inspections Coordinate and follow up responses to inspection reports and ensure that decided actions are implemented on time Review, prepare, and quality approve instructions and other documents Train and coach the organization on quality management systems and quality matters Represent QA in cross-functional investment and Tech Transfer projects Manage and develop the change control process The role involves close collaboration with many functions and gives you the opportunity to build an extensive network both locally and globally within Fresenius Kabi. Travel between our sites in Uppsala and Brunna/Kungsängen will occur. About You We are seeking someone with strong self-leadership combined with experience in quality work within regulated operations who wants to grow with us! To thrive and succeed in this role, we believe that you: Are analytical, thorough, and have a strong quality mindset Have the ability to independently prioritize, make decisions, and drive matters forward Are communicative and skilled at building trust and good collaborations Enjoy training, coaching, and supporting others Are engaged, proactive, and see opportunities for improvement You appreciate working in a changing environment where you can combine strategic thinking with practical implementation. Your Background We are seeking someone who has: Academic education in natural sciences, engineering, or equivalent Several years of experience in quality assurance or quality control within the pharmaceutical industry, medical technology, or equivalent regulated operations Experience interpreting and applying requirements such as GMP, GDP, or ISO standards A strong understanding of quality management systems and quality processes Very good skills in Swedish and English, both spoken and written About the Position The position is a fixed-term employment on probation that transitions to permanent employment after 6 months upon 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 Anna-Karin Sigfrinius at 018-644 645. 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 email or mail. Selection and interviews are conducted 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 verification. At the interview, we ask you to present your diploma and relevant certificates. For the final candidate, a health examination will be conducted at our occupational health service. Employment Type: Permanent employment. Duration: Indefinite.