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Quality Control Specialist
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Position Overview
The selected candidate will oversee Quality Assurance functions related to Takeda's commercial operations within the Iberia Local Operating Company (LOC). This includes the implementation and upkeep of a quality management framework that aligns with the Guidelines on Good Distribution Practice for medicinal products for human use, alongside adherence to local and international regulations, ISO 14001 standards, and Takeda's internal policies.
Key Responsibilities:
• Quality oversight of third-party distribution partners within the country.
• Ensure compliance with legal and corporate standards, including I-SOPs and Local SOPs.
• Develop corrective and preventive measures to foster continuous improvement in critical quality processes.
• Conduct local quality surveillance, engaging with customers on returns, market actions, complaints, and inquiries.
• Maintain relationships with the Ministry of Health (MoH) for Good Distribution Practices inspections and collaborate closely with Regulatory Affairs on communications.
• Assist in geographic expansions and product launch strategies.
• Oversee shipping validation and quality control of distribution processes.
• Collaborate with local stakeholders including Supply Chain, Customer Service, Pharmacovigilance, Regulatory Affairs, Compliance, Suppliers, Medical Affairs, and Marketing.
Accountabilities:
In relation to Takeda products and distribution:
• Review batch release documentation to ensure quality compliance, including packaging materials and FMD adherence.
• Conduct training in quality management and maintain training records for Medical Affairs and GxP roles.
• Manage Change Control and CAPA processes.
• Participate in Management Review Systems and Quality Council meetings, contributing to QMS maintenance.
• Handle market actions and manage product returns through authorized channels.
• Oversee the control of damaged products and manage customer complaints, including counterfeit product issues.
• Address technical inquiries regarding product storage, handling, expiration, and administration.
• Ensure compliance with national laws regarding free sample distribution and storage.
• Approve and maintain supplier relationships, ensuring timely delivery of compliant products.
• Manage import/export requirements, including temperature excursions and transport deviations.
• Control narcotics and hemoderivates in accordance with national legislation, including management of narcotics vouchers.
• Participate in internal and external audits, collaborating on CAPA plans and audit follow-ups.
• Ensure the implementation and maintenance of the Quality Management System in compliance with national legislation and corporate requirements.
Additional Responsibilities:
• Contribute to the development of global quality management systems, providing support at both local and global levels.
• Assist the Quality Head/Lead/RPs within the country.
• Ensure readiness for inspections in the market.
• Support ongoing integration projects related to Distribution and Supply within Takeda.
Qualifications:
Education:
• Bachelor's Degree in a scientific discipline.
Experience:
• A minimum of 3 years of practical experience in the Pharmaceutical Industry, primarily in a QA environment. Knowledge of Supply Chain is advantageous.
• Experience supporting inspections from local authorities.
• Familiarity with working alongside suppliers and customers.
• Experience in a global and matrixed environment.
Skills:
• Strong interpersonal abilities, including the capacity to build authentic relationships, challenge conventional thinking constructively, and work effectively as a team leader or member.
Location: Madrid, Spain
Employment Type: Full-time
