Qualified Person (f/m/d) 100%
Munich, Germany, Germany
Acino AG, based in Munich, is part of the Acino Group, a Swiss pharmaceutical company and a leader in advanced drug delivery technologies with its headquarters in Zurich.
Acino out-licenses its own products and manufactures third party products mainly for the European market. In its commercial operations, Acino has a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region, and Latin America. We operate in some of the most dynamic countries of the world. We value courage, commitment, trust, and empathy and provide an environment that supports initiative and effort. We are proud to be action-oriented and open-minded, with a strong focus on quality and product availability, even in remote and hard to reach areas of the world.
We are constantly expanding our market position with a future-oriented international business strategy. Therefore, we are looking for a dedicated and motivated person to strengthen our team in the quality assurance department.
- Performance of the tasks as a Qualified Person in accordance with § 14 AMG (German drug law) for the manufacture and testing of externally manufactured medicinal products
- Batch certification for the marketing of medicinal products according to EU GMP guidelines, Annex 16
- Coordination, organization and execution of Audits
- Creation, review and negotiation of Technical Quality Agreements with contract manufacturing organizations and service providers
- Qualification of suppliers and service providers
- Processing, review and approval of Deviations, CAPAs, Complaints and Change Requests
- Assessment of PQRs
- Creation and review of SOPs and GMP/registration documents
- Ensure compliance with the EU guidelines for Good Distribution Practice (GDP) and the requirements of the narcotics act
- Coordination of product launches from QA perspective
- Maintenance and further development of the Quality Management System
- Participation in Customer audits and Authority inspections and follow-up of observations
- University degree in natural sciences (e.g. pharmacy, chemistry, biology)
- Required qualification as a Qualified Person according to § 15 AMG
- Several years of professional experience in the industrial manufacture and testing of pharmaceuticals (quality control, quality assurance, production and/or development)
- Excellent knowledge of drug laws and current national and international GMP regulations
- Initial experience as an auditor desirable
- Solid knowledge of MS Office applications
- Knowledge of SAP is of advantage
- Responsible, structured and goal-oriented working method
- Team-oriented, confident and committed appearance
- Strong communication skills and solution-oriented thinking
- Fluent in German & English (written and oral)
This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we look forward to hearing from you! Please use the following link to apply.