Cleaning Validation Specialist – SIP (Ref. NHRL01)

Website HeadcountGroup Headcount Solutions

An experienced Cleaning Validation specialist is required to become a key member of the quality team within a renowned Limerick based Biotech multinational.  This is an excellent opportunity to develop your career while working in a dynamic state of the art facility.

 

Responsibilities:

  • 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.
  • Maintain and update Cleaning/ SIP Validation Plan
  • Schedule of Cleaning/ SIP activities with Manufacturing

Qualifications and Experience

  • Bachelors Degree in Science or Engineering
  • 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
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