Batch Record Reviewer

What you’ll do:

• Perform timely and independent review of executed electronic batch records (eBRs) in MES Syncade.
• Ensures that operations batch records are accurately executed, complete, and ready for QA review.
• Collaborate with Manufacturing and Quality teams to clarify and resolve documentation issues
• Initiate and support in the management of Quality Records (CAPAs and Deviations) for Batch Record review related observations.
• Support preparation of documentation package to enable fast release by QA.
  
  
  

 What we’re looking for:

• Previous experience in GDP and GMP regulated pharmaceutical / API industry.
• Experience in batch record review (preferred eBR) OR in manufacturing is required.
• Ability to identify non-compliance and gaps from quality standards.
• Very good communication skills and interaction with all kinds of interfaces within the organization; strong team orientation.
• Structured, focused and well-organized working attitude.
• Open-minded for new ideas and suggestions; solution-oriented.
• Agile, highly motivated and dynamic drive.
• Ability to produce reliable results under stress.