Seeking a seasoned professional to oversee the certification of batches intended for use in clinical trials. This critical role involves ensuring compliance with EU GMP regulations and maintaining high standards of quality.
Key Responsibilities
* Review and certify batches to guarantee adherence to regulatory requirements, including product specifications and clinical trial applications.
* Manage batch certification processes for products manufactured globally and imported into the EU, covering small molecules, biologics, vaccines, and gene therapies.
* Participate in Health Authority inspections and audits to maintain site licenses and uphold regulatory compliance.
* Coordinate ongoing compliance activities related to clinical trials, encompassing technical and quality agreements with collaborators.
* Collaborate with cross-functional teams to ensure clinical trial supplies meet quality and regulatory standards.
Requirements
* Eligibility to be named as a Qualified Person (QP), with a commitment to maintaining continuous professional development (CPD).
* Proven experience with product disposition, including sterile, non-sterile, biologics, vaccines, or gene therapy, and at least two years in quality assurance or qualitative analysis.
* Recognized pharmacy degree or equivalent qualification.
* Extensive experience in a cGMP environment, preferably within a Quality function for clinical trials or Investigational Medicinal Products (IMPs).
* Strong organizational and communication skills, with a proactive approach to working on global teams and collaborating with internal and external stakeholders.