QA Officer Supplier Management (m/f)

Description

• Perform the qualification of suppliers per quality management system including determining the level of criticality of the supplier in order to decide the level of qualification required
• Design the supplier qualification questionnaire in collaboration with the business entity using the supplier
• Send questionnaire to supplier and evaluate supplier response
• Perform and support supplier qualification audit, supplier monitoring audits and for-cause audits as needed
• Planning, scheduling, performing, documenting the audit and following up on audit findings
• Write Quality Technical Agreements with suppliers
• Issue non-conformances to suppliers as needed
• Manage supplier to ensure proper documentation, investigation, resolution and closure of non-conformances
• Write, revise and review Supplier Management

• Profound experience in pharmaceutical, medical device or life sciences areas
• Excellent knowledge of quality management systems
• Knowledge of regulations (ISO, FDA, ICH, ISO etc.)
• Profound experience in internal and/or supplier audit
, with focus on supplier qualification management
• Knowledge working on non-conformance and/or CAPA
• Fluency in English (written and spoken)