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Data Validation Specialist

hace 2 semanas

Torre Pacheco Campo de Cartagena y Mar Menor Spain PQE Group A tiempo completo

About PQE Group

PQE Group is a world leader in the Pharmaceutical and Medical Device industries. With 40 subsidiaries and over 2000 employees across Europe, Asia, and the Americas, we have been at the forefront of these industries since 1998.

We are currently seeking a CSV Project Manager to join our team in Barcelona, Spain. This individual will be responsible for managing Computer System Validation (CSV) projects, ensuring compliance with GxP regulations, including 21 CFR Part 11 and other relevant guidelines.

Key Responsibilities:

  • Leading and executing CSV projects to ensure regulatory compliance
  • Developing strategies and protocols for laboratory, manufacturing, and enterprise application computer systems
  • Conducting risk assessments and developing mitigation strategies for computer systems
  • Reviewing documentation and performing tests during validation activities
  • Providing expert advice on regulatory requirements and industry best practices for computer system validation
  • Collaborating with IT, Quality Assurance, and Regulatory Affairs teams to ensure project success

Requirements:

  • Bachelor's or Master's degree in Pharmaceutical/Industrial disciplines (Pharmacy, Chemistry, Biology, Engineering, Computer Science, etc.)
  • At least 5 years of experience in the Pharmaceutical sector
  • In-depth knowledge of GxP regulations, 21 CFR Part 11, EU Annex 11, EU GMP, and other relevant guidelines
  • Fluent written and spoken English (at least B2 level)
  • Familiarity with key validation software, test management tools, and computer systems