Expert állások, munkák minőségbiztosítás kategóriában

Collaborate closely with Translational Science Leads (TSL), Clinical Operations, Biostatistics/Bioinformatics, and Data Management teams to execute translational science strategies in clinical trials....

• Scientific lead and coordination of Critical Quality Attributes (CQA) evaluations and product characterization studies
• Representation of Analytical Science in the customer project teams, coordination of activities and implementation of the QbD strategy

You develop, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, MDR, and other applicable regulatory requirements...

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams

Select and qualify packaging suppliers to ensure high-quality materials. Collaborate with suppliers to choose optimal packaging for Fresenius Kabi´s products....

Execution of consulting projects with a focus on developing market access and dossier strategies, including preparation of corresponding workshops, and participation in oral hearings with relevant authorities...

• Lead and develop the Product Risk Management team
• Own and continuously improve the risk management process according to ISOwithin our product development framework
• Ensure high-quality risk analyses and maintain consistent, audit-ready risk management documentation

Acting as subject matter expert for global Quality applications (e.g. Veeva QualityDocs, Veeva QMS, LIMS and related systems), ensuring they remain compliant, user-centric, and fit for purpose....

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities

Deliver technical expertise in the development of container closure systems, including vials, prefilled syringes, and prefilled cartridges, by employing cutting-edge methodologies to conduct comprehensive analyses and evaluations of their protection, safety, compatibility, and performance attributes...

• Drive global CMC strategies for clinical trial applications, new product licenses, and post-approval changes.
• Assess CMC, facility/equipment, and plasma-related changes and manage regulatory submissions in coordination with regional teams.