• Location: Vienna (Hybrid Working - 1100 Wien)
• Job type: Permanent

• Responsibility for planning, coordination, implementation and monitoring Quality Assurance activities across the Austria and CEE region
• Troubleshooting of quality issues arising in Austria and CEE countries;
• Preparation and execution of internal/external GDP/GMP- audits
• Oversight on Complaints, recall handling and Out of Stock-reporting and main contact person for the Austrian competent authority
• Implementation of new processes for Mundipharma (e.g., Change Control) for the region in cooperation with Head of EU Quality and global quality systems.
• Preparation for inspections and audits conducted by external parties
• Preparation of Audits and CEE support in Audits / inspections
• Product Quality Review
• Management of the quality assurance system (in accordance with the current version of EU GDP/GMP guideline as well as national legislations)
• Management of CAPAs (CAPA tracking CEE and follow up) and Deviations
• Management of Quality Agreements, Technical Agreements and Contracts, Maintenance of licences
• Development of required Standards Operating Procedures (SOPs), Quality Manual and SMF
• Oversight on Management of qualification and validation activities (e.g. computer systems)
• NMVO: Serialization contact person, Alert Handling for Mundipharma Products, contracts in the region (maintenance)

• Fluent in German and English
• University degree in Pharmacy, Human or Veterinary Medicine, Dentistry, Chemistry, Biology or food- and biotechnology)
• Proven experience working in quality management in relation to wholesalers
• Strong background with GDP in the pharmaceuticals industry
• At least one year of qualified employment in one or more companies, which have been granted a wholesale license.
• High degree of professionalism and in accordance with the company’s code of Ethics and Business Conduct.

• opportunities for learning & development
• collaborative, inclusive work environment

AT Vienna 2024-11-25 Permanent