Jobs → QA & Testing → CMC & QA Specialist

About the Role Smartedge Client is seeking an experienced CMC & QA Specialist for a remote contract opportunity in the EU, with a preference for candidates based in Germany. Key Responsibilities • Review technology transfer documentation and support manufacturing site transfers • Prepare site-transfer strategy documents and participate in submission strategy discussions • Assess existing CMC documentation for site transfers and identify required updates • Author and review CMC documentation • Coordinate with document owners regarding Module 1 documentation requirements • Conduct peer reviews of regulatory documentation • Identify and mitigate CMC and quality risks associated with site transfers • Support contingency planning and post-publishing reviews before submission dispatch Requirements • Strong experience in CMC (Chemistry, Manufacturing and Controls) and Quality Assurance (QA) • Experience with technology transfer documentation and manufacturing site transfers • Ability to prepare site-transfer strategy documents • Knowledge of Module 1 documentation requirements • Experience conducting peer reviews of regulatory documentation