University/Bachelor Degree preferably in pharmaceutical Biopharmaceutical or Equivalent Experience Generally requires (2-5) years related experience Experienced in utilizing appropriate software to effectively manage a supply chain (e.g. inventory management system) To work with different software systems depending on vend Basic knowledge on GMP or good documentation practices Operational and data analysis skills Good documentation practices GXP Regulatory requirements including CFDA guidelines Technical Safety Standards Excellent knowledge of English (spoken and written) Willing to travel (up to 40%)
Be part of the technical team and discuss packaging design with Clinical Supplies Integrator & manage timelines with Supply Chain Managers.
Ensure financial and payment responsibilities are taken care of: Obtain quotes and ensure approval of the quotes. Review invoices and provide feedback to ensure POs are covered
Coordinate packaging projects with packaging contractors
Negotiate timelines and follow up on the progress of the project to assure timely release and distribution of the clinical material to the clinical site
Deliver all necessary documentation and information
Review packaging instructions and label copy ensure availability of randomization information obtain and/or coordinate pre- and post-packaging approvals.
Escalate potential missed timelines and look for possible solutions to minimize impact.
Assist periodically in monitoring contractor performanceThis information/knowledge must be applied in all projects where applicable hence the following responsibilities:
Setup of the required cross-linked information platforms (QA Manufacturing Prevention PDMS/JSC)
Review Master Service Agreement and define Scope of Work at CMO
Follow-up on orders and invoicing according to project plan
Periodic review and score card monitoring of CMOs
The ESI Logistic Coordinator will help to manage the operational budget as a devoted housekeeper. He/she has strong responsibility with respect to the dedicated operational and project budget.
The ESI logistic coordinator will co-ordinate with Internal and External stakeholders of different function to implement Clinical batch execution as per schedule.
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