**Job Title:** Quality Assurance Specialist for Clinical Trials
At our company, we are seeking a skilled and experienced Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our clinical trial supplies.
**Responsibilities:
• Review and certify batches intended for use in clinical trials to ensure compliance with EU GMP and regulatory requirements.
• Oversee batch certification for products manufactured globally and imported into the EU, including small molecules, biologics, vaccines, and gene therapies.
• Participate in Health Authority inspections and audits to maintain site licenses and ensure compliance.
• Manage ongoing compliance activities related to clinical trials, including technical and quality agreements with collaborators.
• Coordinate with cross-functional teams to ensure clinical trial supplies meet quality and regulatory standards.
• Provide expertise on EU regulations and guidelines, including EudraLex Chapter 4, Annex 13, Annex 16, and EU CTR regulations 536/2014.
• Act as a key contact for quality-related issues, ensuring timely resolution and adherence to standards.
• Support the implementation of process improvements to enhance compliance and efficiency in clinical trial supply management.
**Requirements:
• Eligibility to be named as a Qualified Person (QP), with a commitment to maintaining CPD.
• Practical 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.
• Extensive experience in a cGMP environment, preferably within a Quality function for clinical trials or IMPs.
• Strong organizational and communication skills, with a proactive approach to working on global teams and collaborating with internal and external stakeholders.