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Batch Record Reviewer

Batch Record Reviewer

EPM ScientificSwitzerland
Il y a plus de 30 jours
Description de poste

Key Responsibilities :

  • Independent review of operational paper-based and electronic manufacturing records on schedule :
  • Checking whether the materials used were approved at the time of production
  • Carrying out the audit trail reviews
  • Checking whether required Filter Integrity Tests (FIT) are available and have been successfully completed
  • Check whether trends, parameters and CPP are within the given limits
  • Checking the LIMS labels for correct labeling in the manufacturing protocols
  • Creating and editing CAPAs in the Trackwise system
  • Collaboration in continuous improvement processes in the BRR area
  • Supporting the other BRR departments (QA, BPE)
  • Participation in cross-departmental meetings (QA, BPEs)
  • Implementation of logbook reviews

Requirements :

  • Mandatory : Proficiency in English; German is a real plus.
  • Completed vocational training.
  • Strong attention to detail and excellent documentation skills.
  • High safety and quality awareness.
  • Strong team spirit.
  • Advantageous : GMP experience.
  • Advantageous : Bachelor's degree in science, engineering, chemistry, biology, or a related field.
  • If you meet the requirements and are interested in joining our dynamic team, please submit your application.

    We look forward to receiving your application!