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CQV Engineer

Reference ID : 273MQ
Category :
  • Pharma / Biotech
Date Posted : Mar 27, 2018
Job Location
:
  • Leinster
- Dublin
Experience : Minimum 5 years in a similar role
Salary : Negotiable - DOE
Employment Type
:
Contract
Consultant
:
Michael McQuade
Contact Number : 086-0435195
CQV Engineer will be responsible for working within a cross functional team to ensure that the validation activities associated with process equipment for vial and syringe fill finish processes meets system requirements

Principal Responsibilities

  • Assist in development of Validation Plans and development of Installation Verification, Functional Testing and Performance Qualifications (PQs) for equipment. 
  • Working with the team to ensure all aspects of activity within the commissioning and Validation of equipment adhere to required policies and procedures, including safety and training 
  • Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards 
  • Prepare and execute validation protocols and can complete risk assessments from a quality system perspective. 
  • Assist with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), DQ 
  • Assist in the implementation of any existing Validation program to ensure continued compliance to the necessary regulations 
  • Assist in deviation and exception resolution and root cause analysis 
  • Participate as required in project activities 


Qualifications & Requirements

  • A third level qualification in Science, Engineering or a relevant Quality discipline.
  • Equipment and Systems Qualification Experience up to and including PQ 
  • A third level qualification in Science, Engineering or a relevant Quality discipline. 
  • Minimum 5 years’ experience in a similar role. 

    For further information, please contact Mick on 086-0435195 or forward details in confidence to jobs@headcount.ie


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