CSV support for packaging team
Primarily lead all CQV efforts relating to PACKAGING.
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.
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
LiaiJob Description
CSV support for packaging team
Primarily lead all CQV efforts relating to PACKAGING.
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.
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
Liai
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical