Qualified Person

What you enjoy

• As a Qualified Person, you take on the tasks of the Qualified Person according to 14 AMG and ensure the relevant batch releases
• You will manage a small team of currently two employees in operational, disciplinary and technical terms, who support you with batch certification
• You will supervise new product launches and take part in inspections by the authorities on site and, if also in third countries if interested
• You will be responsible for ensuring and maintaining GxP-compliant QMS systems and working on lean management projects
• The creation of QP declarations, as well as review and evaluation of product quality reviews is also part of your tasks
• In addition, you will act as an interface to our national and international contract manufacturers and assist with supplier evaluations and, if necessary, participation in audits

That makes us curious

• You have many years of experience as a Qualified Person and in drug release
• Ideally, you also have management experience and experience in the release of biologicals
• You are a pharmacist or scientist with extensive industry experience and the required expertise in accordance with 15
• You have many years of experience in the GMP/GDP environment and are proficient in all MS Office programs, SAP and other pharma-specific software
• You have a careful and structured way of working, a confident manner and excellent communication skills characterize you
• Very good written and spoken German and English skills round off your profile

What we offer

• If you are interested, we offer you the opportunity to train as an auditor for audits of contract manufacturers, laboratories or external warehouses
• Varied tasks within an internationally successful group
• A distinctive collegial atmosphere embedded in an appreciative and employee-oriented corporate culture
• An attractive salary and extensive social benefits, such as a company pension scheme, company party, fuel vouchers, ice cream in summer, barbecues, free drinks,
• Flexible working hours with time account and home office option
• Development and training opportunities