Job Description
This is a permanent role that reports into the site Quality Manager, part of the Quality & Validation team.
Main Responsibilities:
* Embed equipment and services into client sites.
* Build strong working relationships with the Cork site manufacturing team and pharmaceutical clients.
Key Activities:
1. Preparation of validation documents (FAT / IQ & OQ protocols)
2. Execution of FAT, SAT, IQ, OQ, CD and PQ activities according to established protocols
3. Project team member actively involved in delivering projects and involved in customer design meetings / URS reviews
4. Design Qualification (Traceability Matrix) of projects
5. Draft and revise testing SOPs and quality documentation
6. Performing risk assessments for equipment
7. Supporting regulatory audits and inspections
Requirements:
* Technical/Scientific qualification with at least 18 months experience in a Validation or Quality role with exposure to Validation principles.
* Quality focused with knowledge and understanding of scientific rationale and c GMP quality systems
* Proven problem solving skills
* Excellent interpersonal skills and the ability to communicate well, both verbally and written
* Familiarity with automation validation concepts and principles
* Open to travelling internationally
* Experience in interpreting P&ID diagrams and electrical drawings is highly desirable