QA Batch Record Reviewer (m/w/d)

QA Batch Record Reviewer (M/F/D)

Making sure the batch was made properly, according to procedure and regulatory requirements. Reviewers should have great attention to detail, be able to work independently, and have a thorough knowledge of the manufacturing process they are reviewing

Tasks :

• Review of the Executed Batch Records (e.g. production documentation review, raw data etc)
• Support batch release by ensuring the completeness of the documentation package
• Review comments added to the Executed Batch Records, clarify with the operations team and evaluate with the responsible QA Manager
• Support the initiation of deviations and investigations for Batch Record review related observations
  

Qualification:

• Academic degree OR relevant work experience in Biology/ Chemistry/ Biotechnology or other related field
• Previous experience in GMP regulated pharmaceutical / API industry is an advantage
• Ability to identify non-compliance and gaps from quality standards
• Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive
• Fluent English (written and verbal) is required, German language skills preferred

Requirements:

Start : 01.01.2025