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CSV Lead

  1. Dublin
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
08-09-2023
32119
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CQV Lead - Dublin - 12-Month Contract 

A global pharmaceutical company require a CSV Lead who has in the past worked to deliver Complex projects.  The role of the CSV Lead will be to lead the CSV activities on all automated/Process Control systems on this fill finish project in Dublin.

Reporting into the CQV Project Manager, this individual will be responsible for leading the CSV activities on a new build fill finish expansion project. 

Responsibilities 
  • 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.
If this role is of interest to you, please apply now! 

The candidate must have the rights to work in the location stated in the job advert.

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