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Batch Release Coordinator - Quality Assurance - Basel

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Proclinical AG are a leading life sciences recruitment agency supporting the pharmaceutical and biotechnology industries throughout Switzerland

Batch Release Coordinator - Quality Assurance - Basel

Proclincal have partnered with a growing Biotechnology organisation to recruit a Batch Release Coordinator for a long term mission.

You would have the responsibility for QA oversight and support of product disposition of clincial products manufactured at contract manufacturing organizations and tested at contract laboratory organizations.


  • Ensure release activities for clinical and commercial drug substance and drug product as well as labeled and packaged products are completed on time and in accordance with international regulatory requirements
  • Coordinate the related activities with Manufacturing, MS&T, Development, QC, QA Operations, QA Systems and Compliance, Regulatory Affairs and Supply Chain to ensure products are dispositioned on time
  • Establish an adequate batch release monitoring process, including the definition of key quality indicators and use of tools such as dashboards.
  • Take part in the deviation handling process and the complaint management proces
  • Review batch records, testing records and other documentation to ensure that all steps have been executed correctly
  • Manage the release inbox and ensure release documentation is provided to customer and health authorities on time


  • Experience in product disposition processes and requirements and cGMP manufacturing and testing within biotechnology industry.
  • Working knowledge of relevant EU and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in participating in successful regulatory inspections.
  • Experience implementing and maintaining quality systems and e-systems in a biopharma organization.Experience in GDP processes oversight, including temperature excursion handling.
  • Experience working with CMOs, CLOs, vendors, and relationship management preferred


Mr John Bowler
Grosspeteranlage 29
4052 Basel

Website https://www.proclinical.com/

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