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Labs CQV Engineer

  1. Midlands (Ireland)
Limerick
  1. Contract
Competitive
  1. CAPEX Projects
01-03-2024
32359

This vacancy has now expired

Labs CQV Engineer - Life Sciences - Limerick - 12-Month Contract

Ireland is a hive of activity for the Life Sciences Sector at present with global players setting up new and expanding existing manufacturing facilities all over the Country. An exciting opportunity has arisen to work via Quanta on the client’s side for a global Pharmaceutical organisation on a major expansion project based in the picturesque Munster region of Ireland. 

Located just 20 minutes from the nearest international airport, the manufacturing site is workable for those wishing to commute to/from Ireland for a contract position. 

Role Summary:
  • Responsible for GMP commissioning and qualification (validation) of laboratory equipment and systems.
  • Work to be done in co-operation with the equipment supplier, IT/Automation, and equipment users. Candidates to have the ability to work independently without supervision where required.
  • Responsible for generating, executing, reviewing, and approving qualification documents per relevant company policies and SOPs.
  • Review of supplier qualification documents
  • Coordination and supervision of service providers/suppliers of laboratory equipment during supplier commissioning and qualification.
  • Witnessing of supplier qualifications.
  • Authoring discrepancies reports and punch lists. Perform investigations of discrepancies arising during qualification activities and definition of appropriate corrective actions.
  • Documentation to comply with GDP/GMP when performing commissioning and qualification testing.
  • Peer review of executed commissioning and qualification tests from other C&Q specialists to ensure protocol complies with GDP/GMP.
  • Support the approval of the executed documents by the user and QA (e.g., answering questions, incorporate corrections).
Requirements: 
  • Knowledge of key GMP processes, e.g., documentation, qualification, change management, user requirement specifications, IQ/OQ/PQ execution.
  • Knowledge of and experience with FDA and EMA regulatory requirements in GMP, 21 CFR Part 11 and EU GMP Annex 11, required.
  • Knowledge of data integrity requirements
  • Knowledge of and experience with GMP documentation and handling of discrepancies/deviations
  • Experience in temperature mapping is of advantage.
  • Knowledge of LabX or Viper nice to have.
  • Experience in CSV nice to have.

If this role is of interest to you, please apply now! 
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