Computer System Validation Professional

hace 2 semanas


Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

About Us
We are Flexible & Integrated Technical Services, Llc, a service provider company that stands out from the rest. We pride ourselves on treating our employees like family and providing them with a flexible and family-oriented work environment.

Job Description

We are seeking a skilled Computer System Validation Professional to join our team. As a key member of our team, you will be responsible for writing, executing, and maintaining CSV protocols in a timely manner. You will ensure that all new and existing protocols are effectively integrated into manufacturing processes and that documentation is thorough, accurate, and entered on a timely basis into the quality system.

Key Responsibilities

  • Write, execute, and maintain CSV protocols
  • Ensure timely, thorough, and complete execution of all protocols, meeting FDA requirements
  • Ensure that all new and existing protocols are effectively integrated into manufacturing processes
  • Ensure documentation is thorough, accurate, and entered on a timely basis into the quality system
  • Investigate product failures, batch failures, and deviations associated with validation sampling and testing
  • Develop documentation of investigations and communicate findings to ensure chance of recurrence is significantly minimized and resolution satisfies validation requirements

Requirements

  • Bachelor's Degree in Life Sciences or Engineering
  • Previous exposure in Computer System Validation activities within the regulated industry
  • Bilingual, Spanish, and English


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