Technical Writer Cleaning Validation Opportunity
Ireland's Life Sciences Sector is thriving, with global players establishing new manufacturing facilities across the country. Quanta has partnered with a leading pharmaceutical organization on an expansion project in Munster region. This 12-month contract position offers a unique chance to work in a picturesque region of Ireland.
Role Overview:
As a technical writer, you will be responsible for various tasks including:
* Deviation and investigation writing experience
* Validation expertise, specifically CIP/SIP and continuing validation
* CIP/SIP issue assessment during study runs and deviation closure
* KAYE validator reporting review experience beneficial
* Project management skills for managing large programs
* Understanding of manufacturing, CIP, and SIP validation equipment
* SIP protocol generation, review, and approval
* Summary report generation and quality background essential
* Continuing validation and assessment generation
* Impact assessment of issues/deviations arising from assessment generation
* Ability to work independently
Essential Requirements:
To be successful in this role, you must have:
* QA validation experience – execution, review & approval of SIP/CIP and continuing validation protocols and closure
* Extensive experience in writing and approving deviations
* Technical writing experience with white papers and site reports
* Experience in continuing assessments
* GDP experience or exposure preferred
* No biochemistry qualifications required
Key Responsibilities:
Your key responsibilities will include:
* Maintaining and updating the Cleaning/SIP Validation Plan
* Scheduling Cleaning/SIP activities with Manufacturing
* Liaising with various departments