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C&Q Lead – Clean Utilities

  1. Cork
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
12-09-2023
32141
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C&Q Lead - Clean Utilities - Pharmaceuticals - 12-months+ Contract 

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

The candidate will have responsibility for the Commissioning and Qualification of WFI Generation and Distribution, Clean Steam Generation and Distribution and Compressed Air distribution systems. 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 turnover binders from the various relevant contractors, including:
    • Review of all construction test packs and verification of all construction quality documents including pressure test, weld inspection, material certification, passivation, loop checks etc.
    • Verification of all operation and maintenance turnover, including manuals, spare parts lists, training documents etc.
  • Generation & Execution of Design Qualification including:
    • Generation of documents in line with Templates.
    • Verification of the design in the relevant vendor design and turnover documents.
  • Generation & Execution of Installation Qualification including
    • 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.
    • Verification (for critical components) of tagging, size/ range, material, installation and design compliance of all components including Instruments, Equipment, Piping, Valves/traps and other components.
    • Verification (for critical components) of construction testing including Pressure Testing, Cleaning / Passivation, Weld Inspection and Loop Checks.
  • Generation & Execution of Operational Verification including
    • 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 & Execution of Operational Qualification including
    • Generation of documents in line with Templates.
    • Verification (for critical elements) of the operation of the equipment including all automated and manual functions.
    • These activities will include leveraging OV where appropriate.
  • Generation & Execution of Performance Qualification including
    • Generation of documents in line with Templates.
    • Verification (for critical elements) of the performance of the equipment in line with URS requirements.
  • Safety Compliance including:
    • 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! 

The candidate must have the rights to work in the location stated in the job advert.

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