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Quality Assurance & Compliance Officer (Maternity Cover)

Winid
๐Ÿ‡ช๐Ÿ‡ธ Spain
Hybrid
2 days ago
  • Regulatory Compliance
  • GMP
  • CAPA
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Actual Talent is the talent acquisition consultancy that offers Executive Search, RPO and Talent Solutions.


Our purpose is to drive the growth and fulfillment of individuals and organizations. We facilitate individuals in finding inspiring opportunities and help organizations discover professionals who will take them to the next level. We do this through talent acquisition and development solutions that focus on people, diversity and inclusion, innovation, and cutting-edge technology.

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About the client:

Our client is a leading international pharmaceutical company with a strong presence in the European market. They specialize in the distribution and commercialization of pharmaceutical medicinal products, committing to high standards of quality, regulatory compliance, and patient care.

Position Overview

  • Job Title: Quality Assurance & Compliance Officer (Temporary Cover)

  • Department: Regulatory Affairs / Quality Assurance

  • Location: Barcelona, Spain

  • Reporting To: Quality Assurance & Compliance Manager

Purpose of the Role

Carrying out QA activities related to the distribution of pharmaceutical products in the EU. You will maintain relationships with external partners (Wholesalers, Distributors) and internal teams, ensuring GDP/GMP compliance and QMS implementation.

Key Responsibilities

  • QMS & Processes: Maintain a compliant local QMS, managing Change Control, Deviations, and CAPA.

  • Returns & Complaints: Handle product market returns and customer complaints, coordinating investigations and market recalls.

  • Quality Reviews & Data: Track Annual Product Quality Reviews (APQR), perform trend analysis, and support Management Reviews.

  • Batch Release & Packaging: Prepare batch documentation for Responsible Person release and review packaging against Marketing Authorizations.

  • Stakeholder & Authority Support: Collaborate with internal departments and manage product shortage notifications with Health Authorities.

Requirements & Qualifications

  • Experience: 2+ years in Quality Assurance within a pharmaceutical company.

  • Knowledge: Deep understanding of QA, GMP/GDP requirements (EEA), and Spanish/European regulatory frameworks.

  • Education: Degree in Pharmacy or a Scientific discipline (BSc).

  • Languages: Excellent level of English and Spanish.

  • Skills: Strong problem-solving skills, high attention to detail, proactive attitude, and great teamwork abilities.

What is Offered

  • Temporary contract (Maternity Leave cover).

  • Location: Barcelona, Spain.

Quality Assurance & Compliance Officer (Maternity Cover) ยท Winid

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