Fecha: 2 sept. 2024 Ubicación: SAB0 - PHARMA SANT ANDREU DE L MisiónEnsure GxP compliance in subcontracted manufacturers management of the Almirall group's pharmaceutical products. Funciones y responsabilidades New business and cross functional projectsIntegration and maintenance of CMO portfolio in ALM IT systems; Trackwise SQM, OfficialList & SKUsParticipation in cross functional teams and projects of CMO products CM Quality Management SystemData collection for Risk assessment of products and CMOsExecution of assigned activities/projects for the defined Annual plansEnsure implementation of KPIsIdentify and propose improvement actions in CM QMSReview and maintenance of CM QMS SOPs Quality oversight of CMOsMaintenance of QA agreementsFollow-up of implementation of CAPAs from audits and inspectionsParticipation in GMP auditsIdentify, propose and execute improvement actions in CMO performance Quality oversight of productsRecord and follow-up of quality events: change control, OOS, deviations and CAPAsCollection of PQRs from CMOsPQRs initial validation and submit for approval (eDMS) Product and MA complianceFollow-up of specific plans related to implementation of new regulations Regular supplyQA Support to regular supply and market disposition when applicable. QA CM developmentEnsure fluent and effective communication with internal and external stakeholders FormaciónEducation: Bachelor Degree in Life science (Pharmacy, Chemistry, Biological sciences or similar subject) Conocimientos específicosGood knowledge and skills in the use of advanced personal computer programs and systems such as Trackwise and eDMS. Ability to influence and collaborate with others, negotiation and proactivity. Languages: Advanced written and verbal communication skills in Spanish and English.Travelling and moving availability. Experiencia2/3 years experience in GMP fabrication environment and contract manufacturers management ValoresCare: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.Courage: we challenge the status quo, we take full ownership and we learn from our success & failuresInnovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.Simplicity: we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.#J-18808-Ljbffr
