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; project management skills are necessary. An understanding of how manufacturing, CIP, and SIP Validation equipment works. Generate/review/approval of SIP protocols. Generation of Summary Reports; strong quality background essential. Experience in continuing validation and generation of assessments for continuing validation. 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 and a consistent 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, and approval of SIP/CIP and continuing validation protocols and closure. Extensive experience in writing and approving Deviations. Technical writing experience has included writing 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
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