Management of the production of clinical investigational medicinal products Parenterals (m/f/d)

In this responsible role of leadership, you take the deputy lead of the preparation of clinical trial preparations for parenteral administration. You bear the operational responsibility for the GMP fair production and optical control of parenteral bulk goods (vials and syringes) for clinical trials. If you bring expertise in aseptic production, enjoy team leadership and want to work in an international, scientific environment, we look forward to your application. This means: Exercise the function as deputy lead of production according to AMG, AMWHV, EU-GMP Guide and other relevant laws and regulations including AbbVie specifications Planning, implementation, monitoring and evaluation of the production of clinical test preparations for parenteral administration Examination and approval of manufacturing documents Examination and approval of deviation reports, validation and qualification documents Processing of deviations, determination of causes and determining corrective and/or preventive measures (CAPA) Responsible for pharmaceutical quality management in the area of responsibility Responsible for aseptic process simulations and contamination control active participation in the preparation and implementation of regulatory inspections and audits Working with the investment planning and commissioning of new plants Member of multidisciplinary project teams to develop medicines and manufacturing processes Leadership, further development and assessment of employees

How to make the difference: Successfully completed study of pharmacy with approval as a pharmacist or comparable scientific studies At least 5 years of experience in aseptic production, in pharmaceutical development or in another GMP-regulated environment At least 2 years of experience as leadership Knowledge of regulatory requirements and their impact on workflows and documentation requirements (national and international drug law, EU-GMP Guide) Business-English in Word and Writing good computer knowledge Structured working with a high self-initiative and willingness to take responsibility High flexibility and readiness to adapt to changing requirements in development projects Excellent oral and written communication skills Representative team and cooperation capability, including in international and multidisciplinary teams

with a diverse working environment where you can do something with an open corporate culture with an attractive remuneration with an intensive onboarding including a mentor*in with flexible working models for a healthy work-life balance with operational health management with comprehensive health and movement programs with operating social benefits with diverse career opportunities in an international organization with high-quality, attractive development possibilities with a strong international network We have been chosen as a “Great Place to Work” and are proud to offer our employees the flexibility that ensures a healthy work-life balance. We take our influence on the environment and society seriously and therefore focus on giving something back regularly. We are committed to justice, equality, diversity and inclusion (EED&I) – that is fundamental to us. This includes the appreciation of different perspectives, the creation of an inclusive culture and the dignified and respectful handling of all employees. .