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Project Validation Specialist

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Job Description

Project Validation Specialist

Job posted by: Lynsey Smith

HRGO are recruiting a Project Validation Specialist on behalf of our client in Folkestone.

The successful applicant will be responsible for working with the Validation Specialist on Quality Management system improvements to existing processes, develops and executes process system validations, and provides manufacturing quality input to Product Development groups. This role is on a fixed term contract for 1.5 years.

Job responsibilities:

  • To conduct regular project surveys to ensure that the site Validation Master plan is kept up to date
  • Provide support to the Validation specialist and project lead to ensure that Root Cause/FMEA are followed and maintained
  • Provide support for operations on technical issue, projects and planned validation activity timelines
  • Work with the Validation specialist to co-ordinate validation activities as required
  • Work with the Validation specialist to manage the operational validation activities within the project
  • Conduct initial validation reviews
  • Write and develop URS's for equipment in the projects namely project dolphin working with project Team
  • Use URS to write and create IQ, OQ and PQ documents.
  • Create FAT and SAT plans with Project team

Skills and Knowledge required:

  • Broad experience of all key areas of Quality Assurance.
  • Working Knowledge of the MDD, MDR, 21 CFR 820, ISO 13485, ISO 14971, ISO 22716.
  • Experience of data analysis, data trending and preparing KPI's.
  • Experience in data analysis and review (including trend analysis) for communication to management teams
  • Excellent ability in communicating complex ideas across a range of groups
  • Excellent interpersonal skills, being a team player and attention to detail
  • Experience of Writing and developing IQ,OQ,PQ documentation

If you feel you have the relevant experience, then please apply with an up-to-date CV. If you have not been contacted within a week, you should assume that you have been unsuccessful at this time.

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