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QA Validation Specialist

Our client in Andover, MA is seeking a QA Validation Specialist with equipment validation knowledge to quality review and approve validation and change control documentation in relation to data integrity remediation activities. This role is looking to last 18 months, with an opportunity to extend.

Responsibilities include but is not limited to:

  • Provide QA review of executed validation documents such as change controls, protocols and test plans, validation testing documents, and deviations.
  • Ensure compliance to governing SOPs, validation plans, and protocols throughout the project.
  • Release equipment back to GMP manufacturing as part of change control.
  • Have the ability to independently assess impact and re-testing requirements in the event of a deviation.
  • Interactions will primarily be between engineering/validation personnel. Some interaction will also occur with operation personnel, lab and Quality Control reps as applicable.
  • Data Integrity- Computer system validation experience would be ideal plus all other equipment validation experience
  • Plasmids project- day to day activities of equipment review, change controls, validation cleaning systems

Experience

  • Bachelor's Degree in engineering or life sciences
  • 5 years of computer validation/QA experience in a GMP environment
  • Experience with change control as a Quality Assurance approver deviation review, validation background, equipment based validation.
  • 1 year of experience with Trackwise change control software (or similar)
  • Good documentation skills
  • Local candidates ONLY

Sthree US is acting as an Employment Business in relation to this vacancy.