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Computer System Validation Coordinator

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 strict regulations and guidelines. Our company has a strong presence in Europe, with headquarters in Barcelona and subsidiaries in Ancona (Italy) and Frankfurt (Germany).

Job Responsibilities

  • Ensure compliance with computer system validation tasks, assessing data integrity and regulatory requirements prior to system acquisition.
  • Participate in the deployment process and post-installation qualification and validation of computer systems.
  • Draft documentation for computerized systems validation, adhering to current regulations and industry standards.
  • Develop and maintain test plans, test scripts, and user acceptance tests, managing their execution.
  • Manage changes in computerized systems, collaborating with Quality Assurance and IT departments to evaluate impact and establish validation requirements.
  • Perform periodic reviews of computerized systems and maintain support software for instrument management.
  • Assist Quality Assurance during client audits and regulatory inspections, addressing computer system validation issues.

Requirements

  • Hold a degree in Engineering (Chemical, Electronic, Mechanical, Electrical, Industrial, etc.), Chemistry, or Physics, with proven experience in computer system validation.
  • Exhibit self-motivation, good organizational/time management skills, and ability to work with minimal supervision.
  • Apply a methodical approach to problem-solving and demonstrate teamwork skills for effective collaboration with Laboratory staff and IT, LIMS, and Quality Assurance Departments.
  • Effectively identify and address queries from laboratory users, working under pressure to meet tight deadlines.
  • Continuously develop system/software knowledge and possess a strong command of the Spanish language and very good English language skills, both spoken and written.