Cleaning Validation Specialist

3 weeks ago


Limerick, Ireland Headcount Full time

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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