• 12 Month Contract
  • Limerick

Technical Writer – Cleaning Validation

Industry : BioPharmaceutical


Summary of Role:

  • Experienced Technical Writer.
  • Experience in Deviation and Investigation writing,
  • Experience in Validation specifically CIP/SIP and continuing validation.
  • Experience in assessment of CIP/SIP issues during study runs and closeout of deviations.
  • Experience in KAYE validator reporting review beneficial.
  • Capable of managing a large program, so project management skills would be necessary.
  • An understanding of how manufacturing, CIP and SIP Validation equipment works.
  • Generate/review/Approval of SIP 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.
  • 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, review & approval of SIP/ CIP and continuing validation protocols and closure.
  • Extensive experience on writing and approving Deviations.
  • Technical writing experience has written a number of white papers and site reports.
  • Technical writing experience for continuing assessments
  • Experience, or some previous exposure to GDP.
  • An administrative role with exposure to GDP (preferred).
  • Attention to detail.
  • ​No Biochemistry qualifications are required.

Duration: 1 year

Location: Limerick

To apply for this job email your details to enquiries@qaresources.com.