Qualified Person Biopharmaceuticals (m/w/d)

Your tasks

• Exercising the role of a qualified person in terms of the required product quality and the economic efficiency of the company
• Ensuring the quality of biopharmaceuticals in accordance with AMG/GMP/cGMP and other external and internal pharmaceutical guidelines
• Representation of the area of responsibility in audits and inspections
• Approval of quality assurance and quality control documents
• Management and coordination of cross-location investigations
• Collaboration in the implementation of new products and projects
• Conducting internal and external audits
• Creation, maintenance and training of biopharmaceutical-related work regulations and design of organisational processes
• Assessment of changes, deviations and complaints

Our expectations

• Completed scientific or technical education (university, technical college)
• Compliance with the requirements of AMBO 2009 for practising as a qualified person
• Experience in the manufacture or testing of aseptic and sterile medicinal products is an advantage
• Several years (at least 5 years) of professional and management experience in production/QC/QA in an international pharmaceutical company
• Comprehensive knowledge of (c)GMP, AMBO, regulatory requirements and relevant country-specific regulations
• Strong management skills and a high degree of personal responsibility
• Highly process- and quality-oriented, assertive and structured approach to work
• Communication skills, negotiating skills, personal responsibility and decision-making skills
• Social skills, resilience, flexibility
• Good application-oriented IT skills (databases, MS Office)
• Excellent written and spoken German and English skills

We offer

• Highly varied range of tasks
• Training opportunities and personal development within the company
• Career opportunities in an international pharmaceutical company
• Attractive, performance-based remuneration (minimum gross annual salary of € 75,000; higher salary depending on qualifications)