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C&Q Lead – Buffer Prep

  1. Cork
Cork
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
28-05-2024
32139

This vacancy has now expired

C&Q Lead - Buffer Prep - Pharmaceuticals - Cork - 12-Month Contract

Located in Ireland, our Global pharmaceutical client is looking for C&Q Lead to join their state of the art pharmaceutical facility.

The candidate will have responsibility for the commissioning and Qualification of 2 nr 4500 Buffer pep tanks, 7 nr 350L dialysis tanks and 2nr dedicated CIP systems and 1 nr COP station. The role will require the leveraging of FAT and SAT activities to minimise the extend of IOQ using the Kneat Solutions platform.


Main Responsibilities
  • Review of all construction test packs and verification of all construction quality documents including pressure test, weld inspection, material certification, passivisation, loop checks etc.
  • Verification of all operation and maintenance turnover, including manuals, spare parts lists, training documents etc.
  • Generation of documents in line with Templates.
  • Verification of the design in the relevant vendor design and turnover documents.
  • Raising of issues as they arise to the Subject Matter experts.
  • Generation of documents in line with Templates.
  • Verification of documentation for critical elements of the system including Execution of Installation Verification including Drawings, Manuals, Preventive Maintenance, Spare / Change Parts and Lubricants.
  • Generation of documents in line with Templates.
  • Verification of the operation of the equipment including all automated and manual functions.
  • These activities, especially for direct impact systems, must be leveragable.
  • Generation of documents in line with Templates.
  • These activities will include leveraging OV where appropriate.
  • Generation of documents in line with Templates.
  • Preparation/ review of effective risk assessments and method statements.
  • Understanding and following all procedures and policies.
  • Reporting and investigation into any safety incidents with Management and Safety group

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

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