Design állások, munkák minőségbiztosítás kategóriában

Investigating and understanding the manufacturing processes and used raw materials, as well as troubleshooting issues and improving process efficiency....

• Develop, modify, and maintain quality evaluation and control systems for materials, in-process parts, and finished products.
• Translate product requirements/specifications into test plans, methods, and fixtures to ensure product reliability.

• 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

• Working with high throughput lab – analyzer
• Routine lab work with infectious samples and leading of own experiments including the analysis of them
• Plan and execute different work packages for the development of molecular diagnostics test

• 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

• Working with high throughput lab - analyzer
• Routine lab work with infectious samples and leading of own experiments including the analysis of them
• Plan and execute different work packages for the development of molecular diagnostics test

• 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

• 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

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 the commercial development of profitable lab testing services
• Lead and develop the lab organization
• Monitoring of the laboratory and all work carried out there, to ensure compliance with relevant internal procedures and regulations

• 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....

• Create, edit, manage and modify all product and process documentation using PLM and ERP software packages.
• Be a part of the Manufacturing team with extensive interactions with the R&D and Quality departments.

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...

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...