Minőségbiztosítás állások, munkák Németországban

• Drive and complete reimbursement applications for the Vibrant product portfolio
• Build and check health economic models that clearly demonstrate product value by using appropriate software tools

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

• Collaborate with cross-functional teams including IT, Quality Assurance, and Operations to ensure documentation and validation of systems according to internal procedures
• Ensure compliance with internal and external regulatory requirements and guidelines
• Maintain the inventory of software applications

In your new role, you will define and implement the global strategy for analytical development, supporting BI's pipeline from early research through candidate characterization and selection to drug product development and launch....

• Increase the visibility and strategic importance of Quality Assurance across the company.
• Maintain, develop, and continuously improve the Quality Management System.
• Ensure compliance with current pharmaceutical regulations, GMP guidelines, and internal procedures.

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...

• Author, own and maintain internal guidance and training documentation
• Collaborate with various functions within the global company, internal and external suppliers and with customers with the objective to share expertise and provide guidance

Lead technical investigations for customer complaints and product CAPAs assigned to R&D, evaluate technical issues that occur during daily use of our systems in hospitals and act as key reference within the R&D team...

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

• Oversee work for timely completion of a complaint investigation and response to the various customers
• Communicate with customers regarding complaints, product issues and returned devices

• Batch record review for API and bulk product for monoclonal antibody prefilled syringes
• Assessment and documentation of product deviations, OOS, and changes
• Quality oversight for relevant service providers, including CMO's, laboratories, technical operations and supply chain

Lead and coordinate the Site-Launch activities and associated teams for internal and external sites and development projects...

• Drive innovation by evaluating and continuously advancing therapies through aerosol inhalation
• Communicate scientific insights effectively and foster strong interdisciplinary collaborations to ensure successful translation into clinical practice