Quality Compliance Officer

hace 3 semanas

Madrid, Madrid, España Takeda A tiempo completo

Position Overview

This position is dedicated to overseeing Quality Assurance activities related to Takeda's product distribution within the Iberia Local Operating Company (LOC). The role ensures that a robust quality management framework is established and upheld in alignment with the Guidelines on Good Distribution Practice for medicinal products for human use, alongside local and international regulations, ISO 14001 standards, and Takeda's internal policies.

Key Responsibilities:

  • Distribution Quality Oversight: Monitor and ensure quality compliance of outsourced distribution partners.
  • Regulatory Compliance: Guarantee adherence to legal and corporate standards, including I-SOPs and Local SOPs.
  • Continuous Improvement: Implement corrective and preventive actions to enhance critical quality processes.
  • Local Quality Surveillance: Engage with customers regarding returns, market actions, complaints, and inquiries.
  • Collaboration with Regulatory Affairs: Facilitate Good Distribution Practices inspections and maintain effective communication with the Ministry of Health.
  • Support for Expansion: Assist in geographic expansions and product launch strategies.
  • Shipping Validation: Oversee quality processes related to shipping and distribution.
  • Stakeholder Interaction: Collaborate with various local stakeholders including Supply Chain, Customer Service, and Regulatory Affairs.

Accountabilities:

In relation to Takeda products and distribution:

  • Quality Management System: Review batch release documentation to ensure compliance and quality of released products.
  • Training Management: Conduct training activities in the quality domain and maintain training records for relevant departments.
  • Change Control: Manage and monitor change control and CAPA processes.
  • Market Actions: Oversee market actions and manage the return of products.
  • Complaint Management: Act as the local complaint coordinator and manage counterfeit product issues.
  • Technical Support: Address technical inquiries regarding product storage, handling, and administration.
  • Supplier Management: Ensure supplier approval and compliance with local regulations.
  • Audit Participation: Engage in internal and external audits, ensuring adherence to quality standards.

Qualifications:

Education: Bachelor's Degree in a scientific discipline.

Experience: Minimum of 3 years in the Pharmaceutical Industry, primarily in a Quality Assurance setting. Experience with inspections and supplier interactions is advantageous.

Skills: Strong interpersonal abilities, capable of fostering authentic relationships and working collaboratively within teams.

Location: Madrid, Spain

Employment Type: Full-time

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