Senior Quality Specialist
hace 1 mes
About the Role:
As a Senior Quality Specialist at Takeda, you will play a crucial role in ensuring the achievement of business success with regards to GDP and quality-related activities in the MCO. You will be responsible for maintaining the AEMPS license of Takeda for Wholesale Distribution of medicinal products and medical devices.
Key Responsibilities:
- GxP-regulated activities including in-country distribution quality, local Health Authority relationships, local quality surveillance, local contract manufacturing / packaging / analytical testing quality oversight, and in-country clinical and medical device activities.
- Work in collaboration with other GxP and non-GxP functions focusing on patient needs, regulatory compliance, and internal standards and SOPs and continuous improvement.
- Key stakeholders support in the Iberia MCO on quality matters and initiatives.
Requirements:
- Responsible Person (RP) deputy for Spain LOC, deciding independently from management about the release, block, or recall of batches.
- Support a harmonized quality approach across the Portugal and Spain LOCs.
- Manage GxP regulated activities in Spain LOC to ensure compliance to Takeda requirements & local regulations, and the supply of quality & compliant products to patients promptly.
What You Will Contribute:
- Coordinate the implementation of Global Quality Management System (QMS) Standards and Standard Operating procedures (SOPs) that are aligned with local requirements.
- Implement Takeda QMS and ensure ongoing compliance to the quality standards and procedures at the LOC both for GDP and R&D activities.
- Develop and maintain GxP related controlled documents in the LOC Quality Management System.
Benefits:
- Opportunity to work with a global pharmaceutical company like Takeda.
- Collaborative and dynamic work environment.
- Professional growth and development opportunities.
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