.By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:This role will be responsible for Quality activities in relation to Takeda Products commercial activities at Takeda Iberia Local Operating Company (LOC). This includes ensuring that a quality management system is implemented and maintained in accordance with the Guidelines on Good Distribution Practice for medicinal products for human use (2013/C 343/01); with local and relevantinternational regulations, local and international legislations, ISO 14001 requirements (in the case of TFE), and with Takeda policy.Key activities of the role:Quality oversight of outsourced distribution partners.Ensure compliance with legal and corporate requirements, as well as the I-SOPs and Local SOPs.Establish corrective and preventive actions as required and promote continuous improvement in critical processes from a quality point of view.Local quality surveillance – connect with customers: Returns, market actions, complaints, inquiries.Good Distribution Practices inspections & work closely with RA in MOH communications.Support geographic expansions and brand plan launches.Shipping validation and distribution processes quality oversight.Identify risks in the quality area, propose CAPA and follow up.Interact with Local Stakeholders: Supply Chain & Customer service, Customers, Pharmacovigilance, Regulatory Affairs, Compliance, Suppliers, Medical Affairs, Marketing.How you will contribute:Batch release documentation of company products to ensure quality, including incidences and complaints solving.Training activities in the quality area and management of staff training records for GxP positions.Change Control & CAPA management and monitoring.Management Review Systems, Quality Council meetings. Collaboration in QMS maintenance.Market action management.Handling of returns and management of returned products to our local warehouse.Control of damaged and broken products.Local Complaint Coordinator & management of counterfeit products.Resolve technical requests regarding products: storage, manipulation, expiry, and administration.Responsible for Annual Environmental Declarations.Control of free samples distribution and storage in accordance with national law.Supplier approval and maintenance.Ensure timely delivery of compliant products applicable to local regulations.Control of narcotics/controlled substances according to national legislation.Participation in internal and external audits and collaborate with CAPA plans follow up/audits closeout.Ensure implementation and maintenance of Quality Management System according to national legislation and corporate requirements
