Computer System Validation Specialist

hace 3 semanas

Barcelona, Barcelona, España Centrient Pharmaceuticals Netherlands A tiempo completo
About the Role

Centrient Pharmaceuticals, a leading manufacturer of beta-lactam antibiotics, is seeking a skilled Computer System Validation Specialist to join its Global Quality department in Barcelona. As a key member of the team, you will be responsible for maintaining the validated state of global IT systems, ensuring compliance with regulatory requirements, and embedding quality and validation in the company's IT approach.

Key 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.
  • Timely escalating problems in the approval process and setting up.
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. Communicates effectively with a diverse audience.
  • Independent and reliable worker.
  • Intercultural skills.
What We Offer

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.

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.

For more detailed information about the role and about the Recruitment & Selection process you can contact us via HRSpain@centrient.com We invite you to visit our website www.centrient.com for information about our company.

Reference check procedures are part of the Centrient Recruitment & Selection Process. You will be contacted when a reference check is required.

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