Computer System Validation Specialist

hace 2 días

Barcelona, Barcelona, España Centrient Pharmaceuticals Netherlands A tiempo completo
Job Title: Computer System Validation Specialist

Centrient Pharmaceuticals Netherlands is seeking a highly skilled Computer System Validation Specialist to join its Global Quality department in Barcelona. As a CSV Specialist, you will play a critical role in maintaining the validated state of global IT systems, ensuring compliance with cGMP, GxP, and other regulatory requirements.

Main Responsibilities:
  • Maintain IT GxP systems in validated status by coordinating validation activities and ensuring timely issuance of validation documents.
  • Execute Change Control governance in line with processes and stakeholders like QA, Finance, etc.
  • Act as System Matter Expert on IT Quality and Validation.
  • Coordinate the Yearly Reviews on validated/qualified systems.
  • Manage validation projects.
  • Perform activities that contribute to the validated state of the systems that are in scope of validation such as change control, testing and organization of test sessions, investigations and preparation/execution of validation protocols and reports.
Requirements:
  • Degree in Life Sciences, Computer Science or related fields.
  • Minimum of 3 years of experience with enterprise systems in a regulated environment.
  • Experience with Application Lifecycle Management Systems is desirable.
  • Fluent in English language (written and spoken).
  • Strong knowledge of GxP regulations, ideally in the field of computer system validation.
  • Good knowledge of cGxP and GDPR requirements.
  • Deep expertise in Computer System Validation for the Pharmaceutical industry.
  • Knowledge in the IT and telecommunications domain.
  • Strong Quality and continuous improvement mindset.
  • Strong communications skills. Communicates effectively with a diverse audience.
  • Independent and reliable worker.
  • Intercultural skills.
Benefits:

We offer a local contract in a challenging, comprehensive, operational environment, with many opportunities for personal input and growth and plenty of discussions with other professionals. The organization is very flat. You have a lot of freedom and responsibility in an open, direct, and informal atmosphere.

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