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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). 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 relevant international 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.
Management of enquiries related to the technical/quality department.
SOPs & Document management. Collaboration in Global procedures implementation at local level.
Promote commitment to Takeda-ism philosophy and values.
Communicate to pharmacovigilance department any adverse reaction following company's internal procedures.
Management of informatics systems used in Quality department (SAP, Trackwise, Veeva Vault).
Health Authorities communications to assure GDP compliance.
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.
Experience working with suppliers and customers.
Experience in a global and matrix environment.
Strong interpersonal skills including the ability to build authentic relationships and cooperate as a team leader or member.
Ability to manage multiple and complex priorities.
Good knowledge of Pharmaceutical Quality Management systems: EU GDPs, ISO standards, GMPs.
Excellent knowledge of local GDP and Controlled Substances regulations.
Good 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. We foster an inclusive, collaborative workplace, united by a commitment to deliver better health and a brighter future.
Empowering our people to shine:
Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to any characteristic protected by law.
Locations
Madrid, Spain
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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