Head of Quality Assurance Process Validation / Qualified Person (m/w/d)

As a specialist in digestive and metabolic medicine and family businesses with global networking, we focus on the development and distribution of innovative medicines for various diseases of the liver, the bile ducts, the intestine and the esophagus to improve human life. We believe that we can only achieve medical progress together. So we are looking for: Professional and disciplinary leadership of the team (3-5 employees) Quality Assurance Process Validation Coordination of process validations among wage manufacturers Coordination of product transfers Implementation of all activities as a person skilled in the art pursuant to § 14,15 AMG Status assignment and certification of drug batches for national and international markets in accordance with applicable legislation (AMG, AMWHV, EU GMP Guide) Final examination and evaluation of batch documentation as well as change control requests, deviations, out-of-specification results and Product Quality Reviews (PQRs) Contact person for pharmaceutical questions as part of the life cycle of products after market launch Close cooperation with the Head of Quality Assurance and other experts

Completed scientific studies Qualification as a qualified person according to §§ 14,15 AMG Experience in the pharmaceutical industry and with national and international GMP regulations Knowledge in the field of process validation Production experience desirable Leadership experience and pronounced communication strength High level of responsibility and structured working Very good knowledge of German and English in word and writing

New Work, Mobile Work and Flexible Working Hours Various benefits such as Hansefit, Jobrad, Germanyticket, kindergarten grant and purchase of additional holiday days Comprehensive onboarding and mentoring program Individual training opportunities International and growing family business with short decision-making and financial independence For questions, Laura Höcklin is available via e-mail at personal@drfalkpharma.de or under the phone number 0761 1514 252. We look forward to your application via our online portal. JOBV1_EN