Sr Computer Validation Specialist III

  • Las Piedras, Las Piedras, Puerto Rico
  • Full-time

Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!

Job Description

  • SME for Generation and execution of CSV protocols. 
  • The CSV SME will develop and execute protocols and test scripts. 
  • Responsible for writing GxP computer validation and 21 CFR Part 11 and Data Integrity related documentation such as assessments, plans, URS, FRS, RTM, UATs, OQs and summary reports. 
  • Experience validating computer and automation systems in manufacturing equipment such as Blenders, Tablet Press, Granulators, Encapsulators, and Film Coaters.
  • Technical writing skills for the creation of protocols is a MUST.

Qualifications

  • Bachelor's degree in Engineering, Computer Science or related field. 
  • 5 years experience with validating computer and automation systems in manufacturing equipment such as Blenders, Tablet Press, Granulators, Encapsulators, Film Coaters. 
  • Technical writing skills for the creation of protocols is a MUST

Additional Information

 

  • Send resume, preferable in Word format.