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 with 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 perspective.
Local quality surveillance connects with customers: Returns, market actions, complaints, inquiries.
Maintain good relationships with the Local MOH for Good Distribution Practices inspections and 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.
Interact with Local Stakeholders: Supply Chain & Customer service, Customers, Pharmacovigilance, Regulatory Affairs, Compliance, Suppliers, Medical Affairs, Marketing.
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 and Quality Council meetings.
Collaboration in QMS maintenance.
Handling of returns and management of returned products.
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 fully compliant products applicable to local regulations.
Control of narcotics / controlled substances according to National legislation.
Participation in internal and external audits and collaboration with CAPA plans follow-up.
Management of enquiries related to the technical / quality department.
SOPs & Document management, collaboration in Global procedures implementation at the local level.
Promote Takeda-ism philosophy and values.
Communicate adverse reactions to the pharmacovigilance department.
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.
Supply Chain knowledge is beneficial.
Experience in supporting inspections from local authorities/global audits.
Strong interpersonal skills.
Ability to manage multiple and complex priorities.
Excellent verbal and writing skills, fluent in English.
Knowledge :
Good knowledge of Pharmaceutical Quality Management systems: EU GDPs, ISO standards, GMPs.
Excellent knowledge of local GDP and Controlled Substances regulations.
More about us :
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals. Takeda is a patient-focused company that inspires and empowers you to grow through life-changing work.
Locations: Madrid, Spain
Worker Type: Employee
Time Type: Full time
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