Quality control engineer állások Külföldön (egészségügy, gyógyszeripar)

Following up on production-related nonconformities, supporting root cause analyses, defining and monitoring corrective actions, and preparing evaluations and statistics of nonconformities...

• Planning and initiation of business cases, definition of the project scope, objectives and deliverables. This includes gathering requirements, assessing feasibility and developing a project plan that aligns with organizational goals
• Monitoring of timelines and budget

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...

• 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 

• You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
• Define together with the CMO effective CAPAs and track the timely implementation

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams