Senior Specialist, Batch Record Review | Sneior Specialist * Batch Record Review - Roche Mannheim

Franz & Wach Personalservice PEN

Mannheim, Baden-Württemberg, Deutschland
Published 6/17/2025

Job Summary

This role offers an exciting opportunity for a Senior Specialist in Batch Record Review to join Roche Diagnostics GmbH in Mannheim, Germany, through Franz & Wach. The successful candidate will be pivotal in ensuring the quality and compliance of pharmaceutical production by meticulously reviewing batch records, managing deviations, and implementing corrective actions. Key responsibilities include processing deviations, CAPAs, and process changes using electronic systems like Veeva, conducting thorough reviews of batch documentation for GMP compliance, and supporting GMP audits. The position also involves driving process optimizations, improving documentation practices, and coordinating batch reviews across various interfaces. This role is ideal for a detail-oriented professional with a strong background in biotechnology or a related field, excellent GMP knowledge, and a commitment to quality assurance in a dynamic pharmaceutical environment.

Required Skills

Education

Bachelor's degree in Biotechnology or comparable studies. Master's degree is desirable.

Experience

  • Professional experience in parenteral manufacturing
  • Experience in processing deviations

Languages

German (Fluent)English (Basic)

Additional

  • Not specified