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Lab CSV

  1. NI & Ireland
  1. Contract
Competitive
24567JL
  1. Commisions, Qualification and Validation
Date Posted13 Mar 2020
Laboratory Validation Specialist  required for a world Leading bio tech organization who are at a Peak phase in establishing an innovative and industry leading manufacturing facility in Dublin Ireland.
 Working in their state of the art Laboratories, the Lab Systems Engineer will be responsible for  Validating varied systems and  bench top analytically equipment
 Key Duties are as follows:

  •  Evaluate systems/equipment in accordance with cGMPs, Part 11, and other regulatory requirements.
  • Input and define User Requirement specifications
  • Working closely with user groups to evaluate, develop, implement and maintain laboratory equipment and systems.
  • To work with laboratory personnel to improve processes, streamline workflow, and increase productivity in laboratory operation.
  • Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment.
  • Developing and maintaining an equipment qualification project plan, as part of the commissioning of new laboratory facilities.
  • Writing wraparound IQ/OQ and PQ equipment validation protocols and associated reports.
  • Accompany vendors and ensure that all documentation is completed prior to and during vendor service engineer site visits when performing routine calibration, qualification, requalification and/or preventative maintenance activities in the QC laboratory.
  • Generation and resolution of protocol discrepancies and deviations that arise as required.
 

Skills:   
  • A minimum of 4 years’ experience in a similar role
  • Subject matter expert for CSV Computer systems validation.
  • In-depth knowledge of Annex 11 and CFR Part 11 requirements.
  • Experience at executing validation, data management and data integrity
  • Knowledge of the methodology, instrumentation and analytical techniques used for biopharmaceutical testing.
  • In-depth understanding of current regulatory requirements for cGMP laboratory equipment validation.

 Please apply now with you CV to be considered for this long-term opportunity. 

 





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