Job Description

The role:

QA Validation Technical Writer required for a multinational client based in Limerick.

The role:

  • Capable of managing a large program, so project management skills would be necessary,
  • An understanding of how manufacturing and SIP/ CIP Validation equipment works
  • Generate/review/Approval of SIP/ CIP protocols
    Generation of Summary Reports and strong quality background essential
  • Experience in continuing validation and generation of assessments for continuing
  • Assessment of impact of issues/ deviations which arise through the assessment generation
  • Ability to work on own initiative
  • Experience in continuing validation and generation of assessments for continuing
  • Maintain and update Cleaning/ SIP Validation Plan
  • Schedule of Cleaning/ SIP activities with Manufacturing
  • Liaise with numerous departments
  • Shows focus & a consistence approach to the role and tasks.
  • Excellent people skills
  • Ensure Training is maintained and current.
  • Follow all EHS/Safety SOP/Policies
  • Actively look for Continuous improvements

Education and Experience:

  • Experienced in QA Validation activities –
  • Execution of SIP/ cleaning and continuing validation protocols.
  • Experience on writing and approving Deviations/ GMP documents
  • Technical writing experience in writing site reports.
  • Experienced Technical writer for continuing assessments
  • Experience in Deviation and investigation writing and data review
  • Experience in Validation specifically SIP/ CIP validation
  • Experience in assessment of SIP/ CIP issues during study runs and closeout of deviations
  • Experience in SIP/ cleaning validation results reporting review beneficial
  • Experience in KAYE validator reporting review beneficial

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