Qualification manager limited to 2 years (m/f/d)

For over 100 years, we have been the family-run company of the technology leaders in dosing, filling and packaging demanding products – from liquid to solid. About 3,400 employees at more than 20 locations worldwide develop groundbreaking solutions, systems and technologies for our four business areas: Consumer, Life Science, Nonwovens and Pharma. Together we do everything we can to ensure that our team is the best in the future. #wecareforpeople

As a Qualification Manager (m/w/d), you are part of Optima Pharma GmbH at the Mornshausen site. You contribute to the development and production of intelligent turnkey filling solutions including insulators and freeze dryers for the pharmaceutical and biotech industry. Future-oriented, sustainable and flexible.

Overall responsibility for the qualification planning, coordination and implementation for freeze dryer projects. Main contact partner for customers during the entire project lifecycle in relation to qualification topics (entry, strategy, etc.) Ensuring compliance with GMP and other regulatory requirements taking into account a dynamic project business. Implementation and creation of risk analyses to identify potential problems in the training processes. Creation and maintenance of qualification documentation (RTMs,TPMs, FAT/SAT protocols, IQ/OQ tests, plans/reports, etc.) as well as ensuring the timely release by the customer. Development and further development of a sustainable and standardized qualification concept and process taking into account the requirements of the EU GMP Guide, as well as taking into account specific customer requirements Training of employees in qualification processes as well as customer training and support in audits

You have completed your studies in electrical engineering, mechatronics, pharmaceuticals or process engineering, or you have successfully completed a technical training with a further training to the technician or master. Their at least 2-year training experience in pharmaceutical machine and plant engineering completes your professional qualifications. Very good English skills in word and writing are of course for you. You are ready for national and international missions (up to 30%) as well as an EU licence. With joy and commitment, you go on your own, structured and quality-conscious projects, are a team player and bring the technical understanding.

Family atmosphere in international business challenging activities in a professional environment Good development opportunities through continuous growth of the Group Flexible working time Extensive training measures