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Job Description 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); local and relevant international regulations, local and international legislations, ISO 14001 requirements (in the case of TFE), and Takeda policy.
Key activities of the role: Quality oversight of outsourced distribution partners.
Ensure compliance with legal and corporate requirements, as well as I-SOPs and Local SOPs.
Establish corrective and preventive actions 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.
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: Quality Management System: Batch release documentation of the 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 and handling of returns.
Control of damaged and broken products.
Local Complaint Coordinator & management of counterfeit products.
Responsible for annual environmental declarations.
Supplier approval and maintenance.
Ensure timely delivery of fully compliant products applicable to local regulations.
What you bring to Takeda: Bachelor's Degree in Pharmacy.
Practical experience of at least 6 years in the Pharmaceutical Industry, primarily in a QA environment.
Experience in supporting inspections from local authorities/global audits.
Strong interpersonal skills and the ability to work cross-functionally and cross-culturally.
Good knowledge of Pharmaceutical Quality Management systems: EU GDPs, ISO standards, GMPs.
Excellent verbal and writing skills and fluent in English.
More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.
Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.
Empowering our people to shine: Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to any characteristic protected by law.
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