Description
A global Market Leading Pharmaceutical company requires a CQV Engineer with experience of Filter Integrity Testing (FIT) to support a large project on their site in Ireland. The project primarily is for a new syringe filling line/packaging building and required alterations to existing buildings to support this.Responsibilities will include but are not limited to:
- Primarily lead all CQV efforts relating to FIT.
-Lead and coordinate all QRAES (Quality Risk Assessments) for all related Systems ensuring all critical aspects are addressed and Final Report issued.
-Lead and coordinate all Test Matrices for related Systems, ensure TM`s include all testing requirements and are approved and under revision control.
-Lead and coordinate Verification Design deliverables (Enhanced Design Review / Design Qualification)
-Review and approval of all Vendor Documentation
-Lead for all Factory Acceptance Testing
-Assist where applicable in Quality Audits for all vendors / suppliers
-Utilise and coordinate EDMQ System for review and approval of Protocols
-Lead for all execution work for related Systems - all IV deliverables
-Walkdowns, Tag Verification, Loop Checks, Static Set to Work (STW), Pre-Start-up Safety Review (PSSR), Dynamic Set to Work (DSTW)
-Lead for all FV deliverables = Start-up, De-bugging, Automation Checkout (ACO), Site Acceptance Test (SAT), Phase and Recipe Testing
-Manage the timely closure of all CQV Punchlist items
-Review and approval of all Vendor Turnover Packages and Field Turnover Packages
-Lead for Mechanical Completion acceptance and Walkdowns
-Prioritise qualification activities in line with the project schedules and business needs
-Prepare CSR`s (Commissioning Summary Reports) for executed documentation
-Ensure all the requirements for the IOQ summary reports are available and good engineering and documentation practices have been followed throughout.
-Liaise with internal and external parties and also vendors.
This is a fantastic opportunity for the right candidate to work with a market leader on a large project.