Job Description
We have a clear commitment: putting best-possible solutions in the hands of medical professionals, enabling them to find the right answer to the challenge they face. Fresenius Kabi is a driver of healthcare for the coming decade. We truly live diversity and value different backgrounds and motivations.
Fresenius – Committed to life!
We save and improve human lives with affordable, accessible, and innovative healthcare products and the highest quality in clinical care.
Our company comprises the operating business segments Fresenius Kabi and Fresenius Helios. With 140 hospitals and numerous outpatient facilities, Fresenius Helios is the leading private hospital operator in Germany and Spain, treating around 26 million patients each year. Fresenius Kabi's product portfolio includes a range of highly complex biopharmaceuticals, clinical nutrition, medical devices and generic intravenous drugs, serving 450 million people annually.
- Select and qualify packaging suppliers to ensure high-quality materials. Collaborate with suppliers to choose optimal packaging for Fresenius Kabi´s products.
- Lead global harmonization projects to standardize packaging specifications and processes. Coordinate closely with international stakeholders from Operations Units and Innovation & Development to identify synergies in our portfolio and run projects to bring global packaging components to the next level.
- Support establishing solid requirements with our suppliers and contracting these in supplier quality agreements.
- Conduct quality audits at our manufacturers to review their processes, improvements and innovations. Ensure that Fresenius Kabi's requirements are met and mitigate risks in our supply chain by addressing gaps and following their implementation with persistence.
- Provide support to Operational Units in addressing quality issues related to packaging materials. Apply your expertise in risk assessment and define corrective actions to mitigate risks associated with Fresenius Kabi's products.
- Encourage effective communication and seamless information exchange across Fresenius Kabi's global packaging network and exchange with our international experts on best practices.
- Support the definition and creation of Fresenius Kabi's supplier management program by contributing to standard operating procedures related to supplier management activities.
- Academic background in (Packaging) Engineering, Material Science, or a related technical field, complemented by 3–5 years of relevant industry experience in packaging related development, production, or quality assurance within the pharmaceutical or medical device sector.
- Extensive expertise in packaging production technologies and understanding of associated packaging defects. This position will support selected packaging categories, e.g. glass, rubber stoppers, thermoplastics, foils, printed packaging.
- Strong background in assessing primary packaging interactions with products, supported by experience in extractables and leachable studies.
- Competencies in quality auditing packaging material suppliers is beneficial.
- In-depth knowledge of GxP standards for packaging (e.g., ISO 15378) and a solid understanding of regulatory procedures across Europe, the US, and China.
- Demonstrated self-organization, accompanied by a proactive and goal-oriented working style.
- Outstanding communication abilities, intercultural competence, and a collaborative approach as an effective team player. Business fluency in both English and German, plus proficiency with IT tools such as MS Office, SharePoint, and SAP.