Qualified Person §15.3 (gn) - Remote

Overview

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