Data állások, munkák minőségbiztosítás kategóriában

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

A minőségbíztosító gyógyszerész és a minőségbiztosítási csapat napi munkájának adminisztratív jellegű támogatása: - dokumentumok (.pdf) tartalmának ellenőrzése, - táblázatok kezelése, szövegszerkesztés, (Excel, Word ismeret), - űrlapok kitöltése és archiválása, - számítógépes rendszerekben történő...

• 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.

• Ensure Data Management activities comply with internal standards and regulatory requirements (e.g., ICH-GCP)
• Support the development and testing of (e)CRFs and data review tools
• Contribute to the creation and maintenance of Data Management documentation

• 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.

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...

• 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

• Act as interface to the analytics representative
• Approve corrections in ProNas and create label data
• Prepare projects (special materials for aliquoting, check packing lists, folders, etc.)
• Assist with and execute trainings
• Issue reserve and stability samples
• Order laboratory materials

• 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.

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

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...

• 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

Provide essential guidance to laboratory colleagues on the planning, execution, and conclusion of analytical tests for in-process and intermediate analytics...

• 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