Quality Assurance Specialist

hace 4 semanas


Sin especificar, España DNA Life Sciences LTD A tiempo completo

Barcelona Based Qualified-Person(QP) OpportunityDNA Life Sciences are currently partnered with a Barcelona based Clinical Research Organization that offers a wide range of analytical services in Medicinal Chemistry to optimize the research, the development and the quality control for innovative, generic and biological drug substances and drug products from the preclinical stage to market.Our Client is currently looking for a Qualified-Person(QP) to join the quality assurance department to join the team in Barcelona.This role would ideal for a any established Qualified Persons(QP's) or individuals with a strong quality and pharmacy focused background looking to move into a Qualified Person role(QP).Responsibility:Review and approve analytical documentation, including CoA, Site Master File, SOPs, and product specifications.Participate in reviewing manufacturing batch records, packaging batch records, and other batch review documents for products awaiting release.Contribute to certifying batches intended for market release (QP release), ensuring compliance with GMP as per the product's marketing authorization.Take part in certifying investigational medicinal product batches for release in clinical trials, ensuring adherence to GMP outlined in the investigational medicinal product dossier.Participate in evaluating deviations, Out-of-Specification (OOS) and Out-of-Trend (OOT) results, complaints, CAPA, and Change Controls.Review Quality/Technical Agreements between the company and subcontractors, particularly regarding batch certification activities.Collaborate in audits conducted by clients or subcontracted manufacturers and provide support during regulatory authority inspections.Contribute to implementing and enhancing quality standards within the company and its subcontractors.RequirementsPharmacy DegreeExperience and strong knowledge of Quality control/assuranceMust have rights to work in Barcelona (Cannot support sponsorship)📍Role is based in Barcelona



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