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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