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Computer System Validation Specialist

hace 2 meses

Barcelona, Barcelona, España Kymos Group A tiempo completo

About Kymos Group

Kymos Group is a leading provider of analytical services for the pharmaceutical industry, adhering to cGMP and GLP regulations. Our company has a strong presence in Europe, with headquarters in Barcelona and subsidiaries in Ancona (Italy) and Frankfurt (Germany).

Job Summary

We are seeking a highly skilled Computer System Validation Specialist to join our team. The successful candidate will be responsible for ensuring compliance with computer system validation tasks, establishing data integrity and regulatory requirements, and participating in the deployment process.

Key Responsibilities

  1. Computer System Validation
  • Ensure compliance with computer system validation tasks, establishing data integrity and regulatory requirements prior to system acquisition.
  • Participate in the deployment process and post-installation qualification and validation.
Documentation and Testing
  • Draft necessary documentation for computerised systems validation in accordance with the instrument life cycle and system complexity.
  • Develop and maintain test plans, test scripts, and user acceptance tests.
Change Management
  • Manage changes in computerized systems in collaboration with Quality Assurance and IT department.
  • Evaluate change impact and establish computer system validation requirements in change control records.
System Maintenance
  • Carry out periodic reviews of computerized systems.
  • Maintain and verify different support software for instrument management.
Regulatory Compliance
  • Assist Quality Assurance during client audits and regulatory inspections in computer system validation issues.

Requirements

The ideal candidate will have a degree in Engineering (Chemical, Electronic, Mechanical, Electrical, Industrial, etc.), Chemistry, or Physics, with proven experience in computer system validation. Required skills include self-motivation, good organisational/time management skills, and ability to work with minimal supervision.

Language Requirements

Spanish language and very good level of English, both spoken and written, are essential for this role.