Vacant job

Fresenius Kabi is a global pharmaceutical company specializing in infusion and nutrition therapies as well as medical technology that saves lives around the world. In Uppsala, they develop and manufacture sterile medicines with high technical complexity - products that are used every day in critical care and treatment.

We are now looking for a Qualified Person (QP) to join Fresenius Kabi's QA organization. This is an opportunity for those who thrive in an environment with close collaboration, clear responsibilities, and the chance to contribute to an important part of the business.

As a Qualified Person, you are an expert in GMP and quality assurance, and therefore responsible for ensuring that each batch released meets all requirements according to good manufacturing practice (GMP), applicable marketing authorizations, and EU regulations. The role involves personal certification responsibility and close collaboration with the entire organization, including QA, QC, production, and engineering.

You will report to the Section Manager QA and QC Operations and be part of a QP team with three additional QP colleagues. The work is daytime-based, located in Uppsala, and travel to the facility in Brunna (Kungsängen Stockholm) may occur.

• Review and approve batch documentation and release batches according to GMP, marketing authorizations, and regulatory requirements.
• Support assessors in evaluating complex deviations, CAPA, change requests, and risk analyses from a QP perspective.
• Collaborate closely with production and QA to ensure robust processes.
• Drive and support improvement work within quality and process development.
• Participate in and prepare the organization for regulatory inspections and external audits.
• Support colleagues in matters related to quality, regulations, and interpretations.
• Act as a key person in decision-making regarding product and process-related issues.

You will gain insight into the entire manufacturing chain from raw material to finished product and become a central voice in matters concerning product quality, safety, and regulatory compliance.

We are looking for someone with experience as a QP who enjoys a role that combines analysis, assessment, and decision-making in collaboration with others and across many interfaces. You have strong integrity, clear professional judgment, and are confident in making decisions even when the information is complex.

You are communicative, engaging, and pedagogical, and you naturally contribute in cross-functional contexts. As a person, you are driven to create order, quality, and improvement in an organization where details matter.

• a natural talent for collaboration and relationship building
• energy and commitment in your daily work
• the ability to work proactively and in a structured manner
• the willingness to contribute to a team where members support, challenge, and develop each other

• Academic degree in natural sciences, M.Sc in Pharmacy (pharmacist) or equivalent
• You meet the requirements according to EU Directive 2001/83/EC, Article 49 and the Swedish Medical Products Agency's regulations (HSLF-FS 2021:102)
• 7-10 years of experience working in a GMP-regulated environment
• Previous experience working as a QP
• Fluent in Swedish and English, both spoken and written
• Experience with sterile medicines is an advantage
• Experience in clinical development is an advantage
• Experience with inspections from the Medical Products Agency/EMA/FDA

Fresenius Kabi offers a senior and responsible role in a family-like environment where close collaboration with various functions is encouraged. You will join one of the leading pharmaceutical companies globally with good opportunities for local and global growth. You will work in a dynamic environment that focuses on both innovation and world-class manufacturing. Welcome to Fresenius Kabi.

Interested? In this recruitment, Fresenius Kabi collaborates with SallyQ. If you have any questions, please feel free to contact Ellinor Crafoord, Senior Recruitment Consultant at SallyQ via email at [email protected]. We conduct ongoing selections, so please submit your application as soon as possible.