Description
A Global Biopharmaceutical organisation in Ireland are looking to expand their CQV department with a focus on their clean utilities equipment on site.Responsibilities:
* Primarily lead all CQV efforts relating to Clean Utilities.
* Lead and co-ordinate all QRAES (Quality Risk Assessments) for all related Systems ensuring all critical aspects are addressed and Final Report issued.
* Lead and co-ordinate all Test Matrices for related Systems, ensure TM’s include all testing requirements and are approved and under revision control.
* Liaise with Document Preparation Lead in relation to all Document Deliverables and Approvals, the output of Documents will be controlled by the Document Generation Tracker, which will generate Milestones and Durations, against which the Lead will be measured.
* Lead and co-ordinate Verification Design deliverables (Enhanced Design Review / Design Qualification.
* Review and approval of all Vendor Documentation.
* Lead for all Factory Acceptance Testing.
* Liaise with Document Preparation Lead in relation to producing Protocols (FAT/IV/SAT/FV).
* Liaise with vendors / suppliers in relation to GEP and GDP requirements for “leverage-able” test documentation.
* Liaise with RV Lead to ensure all RV deliverables are executed as per Project Procedures.