Quality Assurance Expert for Regulatory Compliance

hace 1 semana


Madrid, Madrid, España Takeda A tiempo completo

Company Overview: At Takeda, we are committed to improving people's lives by advancing the frontiers of medical science. We strive to be a leader in global healthcare and our MCO in Iberia is no exception.

About the Role:

The Senior Quality Specialist will play a crucial role in achieving business success with regards to GDP and quality related activities in the MCO. As the Responsible Person deputy for Spain LOC, you will maintain the AEMPS license for Wholesale Distribution of medicinal products and medical devices.

Key Responsibilities:
  • Support the achievement of business success with regards to GDP and quality related activities
  • Maintain the AEMPS license for Wholesale Distribution of medicinal products and medical devices
  • Work in collaboration with other GxP and non-GxP functions to ensure regulatory compliance and internal standards
  • Coordinate the implementation of Global Quality Management System (QMS) Standards and Standard Operating procedures (SOPs)
  • Implement Takeda QMS and ensure ongoing compliance to quality standards and procedures
Salary:

We offer an estimated salary of $80,000 - $110,000 per annum, depending on experience.

Requirements:

To be successful in this role, you will need:

  • A degree in a relevant field such as quality assurance or a related discipline
  • Proven experience in GxP-regulated activities, including quality surveillance and contract manufacturing/packaging/testing quality oversight
  • Excellent communication and interpersonal skills
  • Ability to work independently and as part of a team
Benefits:

We offer a competitive benefits package, including:

  • Health insurance
  • Pension scheme
  • Annual leave
How to Apply:

Please submit your application, including your resume and cover letter, to [insert contact details].



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