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
Proclinical Mr John Bowler Grosspeteranlage 29 4052 Basel .