Sap junior tanácsadó állások, munkák minőségbiztosítás kategóriában

• Support GxP compliance of all activities in the clinical trial supply management, drug-related distribution and storage
• Responsibility for the project-related GxP documentation and maintenance of lists

• Provide support to complete product dossiers, technical files and responses to information requests
• Coordinate and complete documents required by federal agencies, incl. maintaining complex files and electronic document management systems
• Work with project teams to obtain approval for company products

The role combines two aspects: the Technical Support to Regions (TSR-API), which entails addressing any Regulatory Affairs and Quality Assurance needs that arise in the assigned region (EMEA), and the Technical Support to Manufacturers (TSM-API), which involves acting as the central point of...

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

• Global pharmacovigilance product responsibility for the medicinal products
• Monitoring of the benefit-risk profile
• Signal management: signal detection, signal validation, signal evaluation
• Risk management: preparation of risk management plans, supervision of risk minimization measures

• Support development projects at transfer or validation level by executing laboratory work
• Perform immunological tests using various platforms (e.g., Flow Cytometry, ELISA, PETIA, etc.)
• Conduct studies to establish and optimize kit reagents and protocols

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

• 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

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

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

• 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

• 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

• 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

• 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

• Develop clinical trial strategies, shaping study designs based on regulatory requirements, competitive insights and company's research interest.
• Give insights into clinical data sets and evidence for our company's products to internal stakeholders.

• 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

• 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

• 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

• Operate as the primary point of contact taking comprehensive care of the needs of our customers around the world
• Ensure premium customer care through regular, remote and on-site Business Review Meetings (BRM) as well as leading Weekly Business Meetings (WBM)

Independent realisation of production processes: Responsible execution of filtrations and chromatographic applications in production scale (250 to 1000 litres), according to the specifications for the GMP environment...