Development állások, munkák minőségbiztosítás kategóriában

• 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.

• QC of ICSR related activities to ensure compliance to Customer and regulatory agency requirements.
• Case intake activity for ICSRs related performance during the work.
• Ensure the Quality and TAT targets are defined and met.

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...

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....

• 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

• 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

Project Leadership & Strategy: Act as the technical lead for instrument hardware product care team, driving workpackage planning, implementation and resource allocation with line management...

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....

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

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...

• 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

• Risk Identification & Assessment - Analyze risks related to product development, manufacturing, post market, useability, biocompatibility, cybersecurity, vigilance, compliance, etc..
• Implementation of Risk Controls - Develop strategies to minimize risks and improve processes.

• 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.

• 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

• 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.

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...

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

QMS Process Management: Oversee the full lifecycle of changes for PTT owned QMS documents, from change initiation and action item assignment to responsible owners across the global network, driving completion and secure the final "approval to execute" before documentation is made effective...