Qualification Manager - Remote

Overview

The Qualification Manager will independently plan, implement, and document qualification activities for spaces and production facilities, ensuring compliance with GMP standards and internal quality guidelines.

In Short

• Independent planning and documentation of qualification activities.
• Conduct ongoing re-qualification and new qualifications according to GMP standards.
• Coordinate supplier evaluations and manage deviations and CAPA measures.
• Ensure compliance with GMP regulations and internal quality guidelines.
• Optimize and further develop qualification processes.
• Create and maintain relevant documents such as requirement documents and qualification plans.
• Participate in internal and external audits.

Requirements

• Completed studies in pharmaceutical technology, process engineering, or engineering sciences.
• Relevant professional experience in the qualification of production facilities.
• In-depth knowledge of GMP regulations.
• Ideally experience with CSV and SAP.
• Analytical thinking, conceptual strength, and initiative.
• Very good German and good English skills.

Benefits

• Family-friendly environment with room for development and creativity.
• Flexible working hours with time tracking and the possibility to take time off for overtime.
• High work-life balance, especially good compatibility of family and work.
• Free use of the fitness studio.
• Company canteen.
• Possibility for mobile office, if feasible.
• Above-average compensation with many additional benefits.