Minőségbiztosítási munkatárs állások, munkák Svájcban

PURPOSE - The purpose of the role is to represent the Quality department in transport projects by: - Guaranteeing methodological rigor in the development plan and coordinating all qualities activities within the project teams.   TASKS AND RESPONSABILITIES - Ensure that development standards are...

Prepare, support the creation and review and execute the release of all technical documentation for digital health and software products ensuring compliance with applicable standards and regulatory requirements such as IEC, IEC...

• Conducting and scheduling internal and external system and process audits (ISO 9001,, and, as well as IATF), including customer audits
• Evaluating and maintaining data for the environmental management system
• Tracking of CIP, measures from audits and their effectiveness

• Developing and maintaining sterility assurance and contamination control strategies for aseptic processing
• Leading risk assessments for aseptic process, single use systems and critical interventions, and ensuring compliance with authorities relevant Guidance such as Annex 1

• In-process controls, release and stability tests using HPLC-based analytical methods 
• DLS-based analyses; pH, IR, and wet chemical analyses
• Visual appearance test of finished drug product for batch release and stability 

• Implement and maintain quality procedures in accordance with ISO
• Lead or support internal audits.
• Manage and drive the internal non-conformities process until issues resolutions.
• Manage Non conform product segregation and containment actions.

• Oversee product and service quality, including decisions on non-conforming materials
• Manage customer complaints from acknowledgment to resolution and reporting
• Ensure compliance with internal and external standards and regulations
• Maintain and improve the local Quality Management System (QMS)