Senior Quality Specialist

hace 1 mes

Madrid, Madrid, España Takeda A tiempo completo

About the Role:

We are seeking a highly skilled Senior Quality Specialist to join our team at Takeda. As a key member of our Quality Assurance team, you will play a critical role in ensuring the quality and compliance of our products.

Key Responsibilities:

  • Support the achievement of business success with regards to GDP and quality-related activities in the MCO.
  • Responsible Person (RP) deputy for Spain LOC, maintaining the AEMPS license for Wholesale Distribution of medicinal products and medical devices.
  • Manage GxP regulated activities in Spain LOC to ensure compliance to Takeda requirements & local regulations.
  • Coordinate the implementation of Global Quality Management System (QMS) Standards and Standard Operating procedures (SOPs) aligned with local requirements.
  • Implement Takeda QMS and ensure ongoing compliance to quality standards and procedures at the LOC.
  • Develop and maintain GxP related controlled documents in the LOC Quality Management System.
  • Ensure LOC QMS is implemented and aligned with our needs, including a contribution for development and review of QMS documents.
  • Support GDP implementation at Spain LOC, including 3PL oversight.
  • Ensure all relevant LOC colleagues performing GDP-related tasks are trained before performing activities and on a periodic basis.
  • Manage submissions of MIF/OCABR for plasma products in LOC Spain/Portugal.
  • Manage submissions of import/export permits for controlled substances in LOC Spain/Portugal.
  • Implement Supplier Quality Program at Spain LOC according to Takeda Global Quality requirements and regulatory expectations.
  • Perform self-assessments to monitor compliance with applicable procedures and requirements.
  • Manage inspections/audits and ensure LOC audit/inspection readiness.
  • Lead or support local Health Authority communication on product quality issues.
  • Maintain oversight of contracts and quality agreements on LOC level.
  • Help prepare external quality agreement between business partners (distributors) and TPI-IB and/or Manufacturing release sites, as applicable.
  • Support regulatory surveillance and intelligence in the Spanish LOC for new or emerging regulations.
  • Ensure there is quality oversight of local GVP/Devices/Medical related activities.
  • Ensure release to market activities in the Spain/Portugal LOCs are performed to enable continuous market supply.
  • Support any GDP/GxP quality-related activities across the Iberia MCO.
  • Local GxP Training administrator for LOC Spain/Portugal.
  • Strengthen Quality Culture at LOC. Champion a culture of continuous improvement and implementation of best practices.
  • Ensure that Quality Management System is implemented and maintained.
  • Focus on the management of authorized activities and the accuracy and quality of records.
  • Ensure that the products are released/stored/transported/distributed/destroyed on the Spanish market adequately.
  • Ensure effective 3PL oversight.
  • Ensure and supervise a process for release of all received products to the distribution.
  • Ensure that initial and continuous GDP training to key personnel are implemented and maintained and GxP training at the LOC.
  • Coordinating and promptly performing any recall operations for medicinal products.
  • Resolve customer complaints and ensure suppliers and customers are approved and periodic license checked.
  • Approve any subcontracted activities which may impact on GDP.
  • Ensure that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
  • Keep appropriate records of any delegated duties.
  • Deciding on the final disposition of returned, rejected, recalled or falsified products.
  • Approve any returns to saleable stock.
  • Ensure additional requirements imposed on certain products by national law are followed.
  • Report monthly to local Competent Authority the medical products distributed in the country.
  • Ensure product defect reports and stock outs are adequately notified to AEMPS and recall execution in the territory.
  • Attend to management meeting for management review and risk assessment.
  • Ensuring GDP audits are performed according to internal planning.
  • Ensure that non-conform products are decommissioned and destroyed.
  • Notify MAH and Competent Authority in case of non-conform products, recall, potential falsified products according to legislation.
  • Performing tasks to show that Takeda complies with GDP and public obligation are met.
  • Ensure MAH responsibilities are fulfilled for the products where LOC is MAH.
  • Collaborate and partner well locally, within MCO Iberia Q-Team and cross-functionally with stakeholders.

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