Coordinate 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, of which, the Lead will be measured against. ?
Lead and coordinate 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 ? Liaise with Master Project Database Lead to ensure all A&E and Vendor Engineering Lists are loaded and correct within Database Ensure valued input into CQV Schedule and Milestones ?
Assist where applicable in Quality Audits for all vendors / suppliers ? Utilize 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 ?
Liaise and utilize Engineering Change Management System (ECM) ?
Review and approval of all Vendor Turnover Packages and Field Turnover Packages against the VDR and to ensure these support the Validation Requirements for the system ?
Lead for Mechanical Completion acceptance and Walkdowns ?
Liaise with H&S in relationJob Description
Coordinate 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, of which, the Lead will be measured against. ?
Lead and coordinate 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 ? Liaise with Master Project Database Lead to ensure all A&E and Vendor Engineering Lists are loaded and correct within Database Ensure valued input into CQV Schedule and Milestones ?
Assist where applicable in Quality Audits for all vendors / suppliers ? Utilize 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 ?
Liaise and utilize Engineering Change Management System (ECM) ?
Review and approval of all Vendor Turnover Packages and Field Turnover Packages against the VDR and to ensure these support the Validation Requirements for the system ?
Lead for Mechanical Completion acceptance and Walkdowns ?
Liaise with H&S in relation
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
