Senior Quality Specialist

hace 4 semanas

Zaragoza, España Takeda A tiempo completo

.About the role:This role will be responsible for Quality activities in relation to Takeda Products commercial activities at Takeda Iberia Local Operating Company (LOC), which 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:In-country Distribution Quality - 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.Local MOH relationship - 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.Contribute to the identification of risks in the quality area, CAPA proposal, and follow-up.Interaction with Local Stakeholders: Supply Chain & Customer service, Customers, Pharmacovigilance, Regulatory Affairs, Compliance, Suppliers, Medical Affairs, Marketing.How you will contribute:Quality Management System:Batch release documentation of the company products (reviewing packaging materials for batches of products that are controlled substances or for which Takeda LOC is MAH and FMD compliance) to ensure the quality of Takeda products released, including incidences and complaints solving.Training activities in the quality area and management of staff training record for the GxP positions.Change Control & CAPA management and monitoring.Management Review Systems, Quality Council meetings. Collaboration in QMS maintenance.Market action management.Handling of Returns. Management of returned products to our local warehouse and destruction process through an authorized company.Control of damaged and broken products.Local Complaint Coordinator & management of counterfeit products.Resolve technical requests of the 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 fully compliant products applicable to local Regulations. Import/Export requirements, manage temperature excursions and transport distribution deviations, Local Release, MoH local Plasma Product Release.Control of narcotics/controlled substances and hemoderivates according to National legislation

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