Job Description
The Quality Assurance Specialist supports GxP-regulated quality activities across Spain and Portugal, helping ensure patients receive high-quality, compliant products on time. The role covers local quality surveillance, distribution quality, and quality oversight activities, while promoting regulatory compliance, internal standards, and continuous improvement across the Iberia MCO.
This position contributes to the implementation and maintenance of the local Quality Management System, including document management, training, change controls, deviations, CAPAs, complaints, and audit readiness. The role also supports product launches, supplier quality activities, quality agreements, inspections, and key quality reporting, using electronic QMS tools such as Veeva, TrackWise, or similar digital platforms.
The specialist works closely with cross-functional teams including Regulatory Affairs, Supply Chain, and Quality colleagues across Iberia.
Responsibilities may also include support for market release activities, controlled substance permits, plasma product submissions, and health authority communications when assigned, requiring strong collaboration and attention to detail in a complex, regulated environment.
Candidates should have a degree in Pharmacy, around 3 years of experience in pharmaceutical quality assurance or other GxP-regulated areas, and a strong understanding of EU and local quality regulations. Success in this role requires digital dexterity, confidence using quality systems and data, strong communication and problem-solving skills, adaptability, and a commitment to quality, integrity, and continuous learning.
Locations
Madrid, Spain
Base Salary Range:
€37,000.00 - €50,930.00
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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📌 QA Specialist (Madrid)
🏢 Takeda
📍 Madrid