Job Details: CQV Engineer


jobContax

104 Upper Drumcondra Road,
Dublin 9
http://www.jobcontax.com
Please contact: Karen
JobContax was founded in 2001 by Karen McHugh, an engineer passionate about offering quality opportunities to the jobseeker and an intelligent service to the client. Jobcontax has successfully operated as a global market leader and technical specialist within the following sectors:

Construction and Infrastructure

Engineering and Design

Mining - Oil and Gas

Biotechnology and Pharmaceutical

During the past 10 years Jobcontax have expanded our international network across 5 continents. In 2005 we began recruiting for the Australian market and in 2011 we set up our first strategic partnership in WA. In March 2010, we opened our Shanghai office to strengthen our presence in the rapidly expanding Chinese market for highly skilled professionals. JobContax has a strong presence in Canada, Europe and the Middle East.

Jobcontax has built its reputation on its consultative approach. Our understanding of the industries and the businesses and individuals within these industries enables us to facilitate the perfect match between client and jobseeker. From global multinationals to SME?, Jobcontax has become the trusted recruitment partner.
CQV Engineer
Job 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
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

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