Quality Assurance Manager (m/w/d) gesucht

Aktuell unterstützen wir einen unserer Kunden aus der Pharmazie bei der Besetzung der Position "Quality Assurance Manager (m/w/d).

Aufgaben

• Responsible for ensuring quality oversight for purchased API’s (incl. sterile)

• Manage and maintain the approval, qualification and certification status for external Suppliers and maintain all associated quality systems

• Manage escalations of all potential quality issues as per the Novartis escalation policy
• Manage quality issues (e.g. Complaints, deviations, stability failures, regulatory non-compliance identified, as applicable) according to the Quality Agreement
• Ensure suppliers’ investigations are correctly performed and appropriate Corrective and Preventative actions are put in place and in a timely manner
• Responsible for preparing Quality Agreements and Quality Risk assessments for External Suppliers within the responsibility of the team
• Support remediation of any gaps identified in suppliers’ Quality Systems and ensure issues are properly addressed
• Provide the quality presence and input to Technical Meetings with the external suppliers and establish good working relationship with the supplier and the team

• Support to the projects for implementation of new suppliers

• Support implementation and management of CMOs 

• Bachelor or higher in Biochemistry, Chemistry or another related science
• Fluent in speaking and writing English
• 5 years in QA management and or project management (QA Operations, production, QC and/or other relevant operational areas) ; experience with sterile manufacturing is prefered
• Proven track record with FDA, EMEA and other Health Authorities
• Thorough knowledge of cGMP requirements
• Strong understanding of regulatory requirements for pharmaceutical products

Ist diese Stelle interessant für Sie? Dann melden Sie sich gerne telefonisch oder per Mail zurück.