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.
- 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