Validation Specialist

3 settimane fa


Ferentino, Lazio, Italia Thermo Fisher Scientific A tempo pieno
Job Summary

Thermo Fisher Scientific is seeking a skilled Technical Documentation Analyst to support our quality team in ensuring the accuracy and completeness of technical documentation.

Key Responsibilities
  • Technical Documentation Analysis
    • Analyze and evaluate technical documentation related to equipment qualification or requalification.
    • Acquire all necessary information to develop protocols and implement validation activities.
  • Protocol Development
    • Develop and maintain technical documentation, including qualification and requalification protocols.
    • Collaborate with cross-functional teams to define test procedures and ensure compliance with regulatory requirements.
  • Qualification and Validation
    • Ensure the qualification and requalification of equipment and systems.
    • Perform operational activities as outlined in protocols and coordinate with other functional teams.
  • Data Analysis
    • Analyze data collected during qualification activities.
    • Acquire and document data and results, adhering to Thermo Fisher Scientific's quality management system.
  • Qualification Report
    • Develop a comprehensive qualification report, detailing analysis and results.
    • Ensure report accuracy and completeness, aligning with Thermo Fisher Scientific's quality standards.
  • Document Management
    • Accurately archive all documentation produced during qualification activities.
    • Issue qualification dossiers, ensuring traceability and compliance with regulatory requirements.
  • Audit Support
    • Support the QA Compliance team in preparing and participating in audits by regulatory bodies or clients.
    • Provide necessary information and documentation.
Requirements
  • At least one year of experience in the pharmaceutical industry.
  • Proficiency in the English language.
  • Bachelor's degree in a scientific field.
  • Excellent communication and interpersonal skills.


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