Minőségbiztosítási munkatárs állások Svájcban (gyártás, termelés)

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...

• 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)