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A key client of BioTalent are looking for a QA operations manager on a permanent basis. This candidate can be based in either Barcelona (Spain), Sofia (Bulgaria) or Lisbon (Portugal). Candidates based outside of cannot commute to such locations will not be considered.Responsibilities:Provide oversight of CDMO/service provider operations to ensure ongoing GMP/GDP and regulatory compliance.Para ser considerado para una entrevista, por favor, asegúrese de que su solicitud se ajusta plenamente a las especificaciones del puesto que se encuentran a continuación.Conduct quality audits of Suppliers/CDMOs and ensure implementation of CAPA plans.Review and approve extensive quality and technical documentation, including specifications, batch records, validation documents, and risk assessments.Continuously assess CDMO/service provider processes and recommend quality and operational improvements.Negotiate and manage Quality Agreements with Suppliers, CDMOs, and other third parties.Support regulatory inspection readiness activities for Suppliers/CDMOs.Participate in due diligence assessments for new product dossiers and potential partners.Monitor and report on Quality Management System performance and support quality risk assessments.Deliver GMP/GDP training, coaching, and promote a strong quality culture internally and externally.Collaborate with global teams and support budget management and broader Quality Assurance activities as needed. xsgfvud Qualifications:Minimum 5 years in quality assuranceQP qualification is a bonusOSD or generics experienceExcellent communication skills in EnglishGMP pharmaceutical experienceReach out for further information.
