Quality Assurance Engineer – Batch Record Review | Ingenieur (m/w/d) Qualitätssicherung – Batch Record Review (1604)

Brüggen Engineering GmbH

Mannheim, Baden-Württemberg, Deutschland
Published Jul 25, 2025
Full-time
Permanent

Job Summary

As a Quality Assurance Engineer specializing in Batch Record Review, you will play a crucial role in ensuring the highest production standards within the pharmaceutical industry. Your daily tasks will involve meticulously reviewing and approving manufacturing instructions and rebookings in compliance with GMP regulations, as well as managing batch records to meet Order Lead Time (OLT) requirements. You will also contribute to audit preparations, develop and update Standard Operating Procedures (SOPs), and conduct internal staff training. This position is ideal for a detail-oriented professional with a strong background in biotechnology or a related field, excellent GMP knowledge, and experience in pharmaceutical documentation. You will contribute to process optimization, data analysis, and the implementation of new Electronic Batch Record (EBR) systems, making this an attractive opportunity to directly influence product and process quality in a dynamic team environment.

Required Skills

Education

Degree in Biotechnology or comparable field

Experience

  • Professional experience in pharmaceutical production
  • Experience in parenteral manufacturing (ideally)

Languages

German (Fluent)English (Fluent)

Additional

  • Not specified