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Quality Assurance Analyst

hace 2 meses

Madrid, Madrid, España Takeda A tiempo completo

Position Overview

This position is pivotal in overseeing Quality Assurance activities related to Takeda's product distribution at the local operating company. The role entails the implementation and maintenance of a robust quality management system, ensuring compliance with Good Distribution Practice guidelines, local regulations, and Takeda's internal policies.

Key Responsibilities:

  • 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: Develop corrective and preventive actions to enhance critical quality processes.
  • Local Quality Surveillance: Engage with customers regarding returns, market actions, and complaints.
  • Collaboration with Authorities: Work closely with local health authorities on Good Distribution Practices inspections.
  • Support for Expansions: Assist in geographic expansions and new product launches.
  • Shipping and Distribution Quality: Oversee quality assurance in shipping validation and distribution processes.
  • 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 product quality and address any incidents or complaints.
  • Training and Development: Conduct training in quality management and maintain training records for relevant departments.
  • Change Control Management: Oversee change control and CAPA processes.
  • Market Actions: Manage product returns and oversee the destruction process in compliance with regulations.
  • Supplier Management: Ensure timely delivery of compliant products and manage supplier approvals.
  • Audit Participation: Engage in internal and external audits, ensuring compliance with quality standards.

Qualifications:

  • Education: Bachelor's Degree in a scientific discipline.
  • Experience: Minimum of 3 years in the pharmaceutical industry, preferably in a QA environment.
  • Skills: Strong interpersonal abilities and a collaborative mindset.

Location: Madrid, Spain

Employment Type: Full-time