The Qualified Person is responsible for the release of batches and their certification, ensuring compliance with GMP standards and participating in audits.

In Short

Release and certification of batches
Evaluation and processing of deviations, changes, and CAPA measures
Review of batch records and product quality
Ensure GMP compliance and AMWHV requirements
Collaboration with production, quality assurance, and quality control
Active participation in audits as a Subject Matter Expert
Management of complaints for defective batches
Continuous development of the quality management system (QMS)

Requirements

Approval as a pharmacist or a degree in a scientific field
Existing authorization as a Qualified Person under §14 / §15 AMG
Experience in batch release and certification
Expert knowledge of pharmaceutical GMP requirements in a sterile environment
Organized, structured, effective, and independent working style
Fluent in German and English

Benefits

Above-average compensation with many additional benefits
Flexible working hours with time tracking and the possibility to take time off for overtime
Modern and international working environment
Opportunities for personal and professional development
30 days of vacation
Bonuses and rewards for every employee
Possibility for mobile work