Computer Systems Validation Lead

Job type:
on-site
Start:
n.a
Duration:
12
From:
Morgan McKinley
Place:
Limerick
Date:
04/11/2013
Country:
flag_no United Kingdom
project ID:
519684

Warning
This project is archived and not active any more.
You will find vacant projects in our project database.

Computer System Validation (CSV) Lead

Description

  • The Computer System Validation Lead is responsible for ensuring that computerized systems are in full compliance with regulatory requirements, company policies and procedures.
  • This individual will provide compliance leadership, direction and execution in Computer System Validation for a large scale and exciting new project.
  • This individual will work closely with the IT Program Manager to ensure CSV activities are planned, managed and executed successfully.
  • Support activities include, but are not limited to, SOP creation, documentation review and approval - including change controls, assessment plans, risk assessment reports, compliance plans, user requirements, system and user acceptance testing protocols, traceability Matrix, error reports/defect report forms and summary reports.
  • Individual will manage the release of regulated systems for GxP production use.
  • Individual will support the resolution of project deviations/errors and provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 11, 820 and Annex 11.) Individual will lead and participate in project teams and may participate in regulatory inspections (eg FDA.)

Qualifications

  • A minimum of a Bachelors degree and a minimum of 6 years of related industry experience OR an advanced degree with a minimum of 5 years of experience is required.
  • A focused degree in a technical, scientific or related field is preferred.
  • A minimum of 3 years of experience in CSV system development life cycle is required.
  • Validation experience with ERP, MES, LIMS, and Quality Systems is preferred.
  • Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 is required.
  • Strong knowledge of system development life cycle is required
  • Knowledge/familiarity with U.S. and Global regulatory registration of drug products is preferred.
  • The ability to work and make decisions independently and have the flexibility to adapt to changing priorities is required.
  • Strong leadership skills and the ability to work in cross-functional team environments, as well as independently, and to manage multiple and competing projects are required.
  • Strong written and verbal communication skills are required.
  • The ability to travel up to approx. 10% (domestic and international) is required.