Junior tanácsadó állások Svájcban (minőségbiztosítás)

• Support validation activities for equipment, processes, and systems
• Assist in the preparation and execution of validation protocols (IQ/OQ/PQ)
• Review and maintain GMP documentation
• Collaborate with cross-functional teams such as Production, Quality Assurance, and Engineering

• 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.

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...

• Development new formulations: contribute to design of studies, perform experiments and prepare reports
• Develop analytical methods (e.g. HPLC)
• Prepare and characterize large number of formulations following DOE
• Assist in the development of methods to characterize formulations or raw materials

• 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

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...