Computer System Validation Professional

hace 2 semanas

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

Centrient Pharmaceuticals, a leading manufacturer of beta-lactam antibiotics and provider of next-generation statins and anti-fungals, is seeking a skilled Computer System Validation Specialist to join its Global Quality department in Barcelona.

Job Summary:

The successful candidate will be responsible for maintaining the validated state of global IT systems, ensuring compliance with applicable regulations, and embedding quality and validation in the company's IT approach.

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.
  • 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.

Requirements:

  • Degree in Life Sciences, Computer Science, or related fields.
  • Minimum of 3 years' 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.
  • Independent and reliable worker.
  • Intercultural skills.

What We Offer:

A local contract in a challenging, comprehensive, operational environment with many opportunities for personal input and growth. A flat organization with plenty of freedom and responsibility in an open, direct, and informal atmosphere.

How to Apply:

Please submit your application via the 'apply' button and upload your CV & cover letter in English. We also ask you to include information on your current remuneration. Only applications with CV and Cover Letter will be considered.

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