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CQV Lead

Project Delivery Partners
Basel, BS

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Details zur Stelle

Qualifikationen

Management-Erfahrung
Schreibfähigkeiten
Englisch

Vollständige Stellenbeschreibung

CQV Lead

Job Description:

Job Summary

The CQ Technical Lead is responsible for planning, preparation, coordination and leading a CQ team from documentation preparation through FAT, CM oversight, MC, integrated CQ execution and successful handover to the Client USER team.

The scope of CQV activities relates to Process and Process Support Equipment. The CQ SME will lead and coordinate a CQV team that consists of CQV leads/specialists, engineers, operations personnel, engineering and external vendors, contractors, sub-contractors including the automation integrator and CSV service provider.

Aside to delivering in line with the Client C+Q requirements, the CQ Lead will ensure that overall Budget, Baseline Schedule, Compliance, Quality and HSE objectives are achieved in line with Project expectations. The CQ Lead will form part of the Client leadership team attending core team meetings, providing guidance on CQ matters and representing PDP in terms or contractual obligations.

Main responsibilities

General Management and Coordination in conjunction with the Client and PDP Team :

Development of an overall level 3 CQ plan in conjunction with the Client project scheduler
Meeting and delivering key project milestones
Lead various weekly multidisciplinary CQV, Eng, CM and USER coordination meetings
Org chart maintenance and resourcing
Approval and tracking of holidays
HSE and Safe Start-Up including PTW and LOTO
Implementation of CORP-35 and supporting guidelines
Adherence to EU Annex 15
CQV Doc Preparation
CQV Execution Readiness
CQV Execution
MC, P+ID Walk down and Punch item Categorisation
Deviation Management & Change Control (Process and Automation)
Punch List Management
Vendor Management
Reviewing CQ test plans and specifications prior to their approvals
Development and maintenance of training material, matrix and files for all those involved in CQV activities (Integrator, CSV provider, Vendors, Client USERs)
Management and Filing of CQV related documentation
Management and Coordination of CQ execution activities, including:
System and Area Handover

Main responsibilities and tasks relating to CQV documentation include but are not limited to:

Setting up the Doc Prep team
Ensure coordination meeting are in place
Defining workflows and approval cycles for CQ test plans and specifications
Coordinating development and approvals with the Client lead, Construction QA lead, and with other disciplines including Vendors, Automation, E+I, and USER etc.
Developing positive working relationship with team members and USER groups
Ensuring adherence to schedule, manhours and quality
Support Prep team as required

Execution Readiness:

FAT support where requested
Documented training on PSPs
CQ Team development and resource and allocation
Monitoring and coordinate MC readiness
CQV documentation readiness
Monitoring and coordinate Automation readiness
Monitor and coordinate SUT installation
Appointment of Sub Contracts
Calibration readiness including test equipment and resourcing
HSE Plans, System PSSRs and LOTO device readiness
Vendor notification of SAT dates per CQ Schedule
Materials, consumables, spares, first fill available in stores
Ensuring the fulfilment of the general pre-requisites, needed to start with CQV execution

CQV Execution:

Ensure daily multidisciplinary CQV, Eng, CM and USER coordination meetings are established
HSE management in conjunction with HSE Lead
MC acceptance
Manage CQV execution activities in conjunction with area CQV Leads
Ensuring compliance of the commissioning activities with qualification requirements where test results are subject to leveraging (FAT, CTOD and SAT)
Tracking of changes, punch items and deficiencies
Reviewing first of type CQV test reports prior to their approvals
Assisting system leads/engineers with system handover to production
PQ and PPQ support where necessary

Project Controls:

Planning & Scheduling
Development of an overall System based baseline CQV Schedule in conjunction with Engineering, CM and USER Group involving;
System Definition
System Classification
MC alignment with Construction
Handover alignment with USER
Fortnightly updates to CQ schedule including actualized and forecasting data for Doc pre and Execution Phases
Liaise with PMO and USER with inputs to PQ and PPQ schedule
Progress Reporting
Development of a monthly project report including but not limited to:
Contracts
Develop scope of work(s) for CQV related vendors and contractors
Approval of invoices based on progress and or timesheets
Progress measurement
Invoice approval and stage payment
Cost
Manage overall cost on behalf of PDP/Client for CQV activates (Directs and Indirects)
Scope including schedule delay management and related change control
Man-hour and cost management

Key Performance Indicators

Strong knowledge and experience of Process Commissioning and Qualification.
Management: Compliance with a schedule at a system and area level with the planned resource levels.
Feedback from customer (i.e. Quality, HSE, operations)
Safety: No lost time accident
Quality: well-executed testing with minimum rework and re-execution.
Quality: all deviations resolved to Client satisfaction and handover completed for all systems.

Ideal Background

Experience in Process Commissioning and Qualification.
Languages: English - fluent in speaking and writing.
Experience: Minimum 10 yrs.
Broad knowledge of engineering disciplines, commissioning, compliance, qualification and quality aspects of biopharma or pharmaceutical manufacturing.

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