Senior Quality Assurance Specialist

hace 4 semanas


Madrid, Madrid, España Takeda Pharmaceutical A tiempo completo
Job Title: Senior Quality Assurance Specialist

About the Role:

As a Senior Quality Assurance Specialist at Takeda Pharmaceutical, you will be responsible for ensuring the quality of our products and processes. This includes implementing and maintaining a quality management system that meets local and international regulations, as well as ensuring compliance with corporate requirements and I-SOPs.

Key Responsibilities:

* Conduct 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 point of view
* Local quality surveillance - connect with customers: Returns, market actions, complaints, inquiries
* Support geographic expansions and brand plan launches

Interacting 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, Quality Council meetings. Collaboration in QMS maintenance
* Market action management and handling of returns
* Control of damaged and broken products
* Local Complaint Coordinator & management of counterfeit products
* Responsible for annual environmental declarations
* Supplier approval and maintenance
* Ensure timely delivery of fully compliant products applicable to local regulations

Requirements:

* 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
* Strong interpersonal skills and the ability to work cross-functionally and cross-culturally

What You Bring to Takeda:

* Strong knowledge of Pharmaceutical Quality Management systems: EU GDPs, ISO standards, GMPs
* Excellent verbal and writing skills and fluent in English

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