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QA Validation

  • Location:

    Republic of Ireland

  • Contact:

    Noreen Daly

  • Job type:

    Contract

  • Contact phone:

    +353 21 485 7200

  • Industry:

    Biotechnology

  • Contact email:

    noreen_daly@oxfordcorp.com

Job Description

QA Validation within the Commissioning & Qualification, role will require involvement in relevant Facility & Utility project validation activities at the Client's manufacturing site.

Responsibilities

  • The Consultant will help develop, maintain and continuously improve the qualification and validation activities within key project timelines / deliverables. Will report to QA Leader

Requirements

  • Preparation, review and/or approval of Qualification/Validation Documents (e.g. specifications, validation plans/reports, User Requirement Specifications, DQ, IQ, OQ, PQ, PV/CV, RTM, risk assessments, SOPs) in relation to instrument, equipment, facilities, utilities, automated systems and manufacturing processes for the introduction of a new product filling line
  • Review and approval of 3rd party generated protocols and reports
  • Participate in equipment, process and/or design FMEAs along with SLIA's & SRA.
  • Identify current and anticipated requirements for compliant facility & utility systems within the manufacturing environment
  • Ensure the archiving and filing of validation documentation associated with the project
  • Provide clear communication to all relevant stakeholders where quality related challenges are envisaged and provide quality SME support to proactively drive solutions within a cross functional, customer-orientated environment
  • Prepare data/presentations and attend review meetings
  • Approval of GMP related documents within the project
  • Ensure that current quality standards / regulatory requirements are interpreted appropriately and implemented in line with project remit
  • Participate in regulatory / internal audits as relevant