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Utilities Specialist

Reference ID : 01922MQ
Category :
  • Pharma / Biotech
Date Posted : Jun 19, 2020
Job Location
:
  • Dublin
Experience : Minimum 5 years
Salary : Negotiable - DOE
Employment Type
:
Contract
Consultant
:
Michael McQuade
Contact Number : 086-0435195
Headcount Solutions is recruiting a Utilities Specialist to join team at our clients biotech facility in Dublin.

Principal Responsibilities

The job-holder will work as part of a multi-functional utilities team and will be responsible for the qualification, validation maintenance, revalidation and periodic review activities associated with GMP Critical Utility equipment and systems

  • Generation of qualification risk assessment/testing matrix for qualification protocols and supporting documents in line with User Requirements/Equipment Specifications/ MSD and cGMP compliance standards.
  • Preparation and approval of Utilities Validation and Validation test equipment SOPs
  • Management of Validation Test equipment with support from site maintenance management team. (Calibration/System Maintenance and Calibration Event handling)
  • Develop, review and execute GMP critical utility Performance Qualification (PQ) protocols and PQ reports for GMP Critical systems e.g. HVAC, RO/PW/WFI, Clean Steam, Clean Compressed Gasses, walk in cold storage.
  • Equipment/System assessments for ‘Computer System Qualification’ requirements and ‘Execution of Electronic Records and Electronic Signatures’ requirements.
  • Identify, document and track validation events
  • Full oversight of all personnel and contractors participating or executing PQ activities
  • Responsible for ensuring documentation being leveraged for PQ testing from project commissioning phase/IQ/OQ are referenced as per associated qualification, referencing procedures.
  • Responsible for validation tasks/actions associated with quality system change controls and investigations where required.
  • Development/Generation of Utilities Validation Master Plan.
  • Periodic review and revalidation assessment.

Qualifications & Requirements

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



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