Cqv Lead

il y a 5 jours

Toulouse, France QCS Staffing Temps plein

**CQV Lead - Pharmaceuticals - Toulouse - 6-Months+**

Our client, a global biotechnology organisation, is recruiting for a CQV Lead to join their capital project in the South of France. This new build facility will house a therapeutic protein production plant, and we are looking for a CQV Lead to help expand our client's biotech operations throughout Europe. As the CQV Lead you will be responsible for implementing all safety requirements for a new build facility, estimated at approximately 14,900m2.

**Reporting into the CQV Project Manager, this individual will be responsible for leading the CSV activities on a new build project**:

- CSV CQV Lead for generation of all CSV Master Plans and Documents.
- Lead engineer for review of PAS, both existing and new. BMS, EMS, Data Historian, OSI Pi and Equipment PLC systems.
- Liaise with CQV PM in relation to CSV portion of Project Schedule.
- Manage CSV Group for Project from Design through to PPQ Stage.
- Identify full scope of all Computer System Validation Qualification effort to be implemented for the Project, both GMP and Non-GMP Systems.
- PLAN-Computer Systems Validation Master Project Plan for the Automation & IT computer Systems, PLAN- Validation Project Plan (VPP) for PAS and OEM Automation Computer Systems, PLAN- Validation Project Plan for OSI-Pi Site Historian and PLAN-Computerized Systems Validation Project PLAN for Standalone QC laboratory instruments.
- Support Automation Group in field execution and Final Report writing. Lead and coordinate the APCC (Automation Project Change Control).
- Have overall management and control of all automation lifecycle and testing documents.
- Also responsible for generating all Automation/CSV Project Templates.
- Support Design Qualification effort in relation to all CSV and Automation input for DQ and DQ Reporting.
- Attend Risk Assessments sessions, representing Automation/CSV, including; Complexity/Customization, FMEA, Product Contact List (PCL) and Critical Instrument List (CIL).
- Lead and manage CSV Team, ensuring at all times that all CSV schedule deliverables are met.
- Coordinate and manage all CSV vendors, from FAT/SAT/IOQ.
- Run and coordinate Weekly CSV Meeting, reporting back to CQV PM on deliverables.

**Requirements**:

- Previous experience of working on and delivering a Verification / Leveraging approach Project for CSV work scope.
- Minimum of 15-20 years experience implementing and managing CSV scope on Large Scale Projects.

LI-CO1

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