Technical Writer Cleaning Validation
Ireland's Life Sciences sector is thriving, with global players establishing and expanding manufacturing facilities across the country. A significant opportunity has arisen to work on a major expansion project for a global pharmaceutical organization in the Munster region. The project site is located near an international airport, making it accessible for commuting.
Role Summary:
* Experienced technical writer
* Deviation and investigation writing expertise
* Validation experience, specifically CIP/SIP and continuing validation
* CIP/SIP issue assessment during study runs and deviation closeout
* KAYE validator reporting review capability beneficial
* Strong project management skills for managing large programs
* Understanding of manufacturing, CIP, and SIP validation equipment
* Generation, review, and approval of SIP protocols
* Summary report generation and quality background essential
* Continuing validation experience and assessment generation
* Impact assessment of issues/deviations arising through assessment generation
* Able to work independently
* Maintenance and update of Cleaning/SIP Validation Plan
* Schedule of Cleaning/SIP activities with Manufacturing
* Liaise with multiple departments
Must Haves:
* QA Validation experience – execution, review, and approval of SIP/CIP and continuing validation protocols and closure
* Extensive experience in writing and approving deviations
* Technical writing experience, including white papers and site reports
* Technical writing experience for continuing assessments
* GDP experience or exposure
* Administrative role with GDP exposure (preferred)
* No biochemistry qualifications required