Technical Writer, Cleaning Validation

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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

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