CSV Engineer - Nottingham

  • Location
    Nottingham, Nottinghamshire
  • Category
    Science - Consultancy
  • Job type
  • Industry
  • External Reference


The Nottingham site is looking to take one to two products into commercialization.

We need to make sure that the internal computer validation of all our systems (60 systems) is completed before an FDA inspection around September 2019.

Prior, to this we are aiming to validate around 16 key systems that affect our ability to move to commercialization for two key products, which has been scheduled to go through an MHRA audit mid-February.

We are in the process of performing data integrity assessments on all of our computerised systems (60 systems) to identify any gaps and perform the remedial actions.

To allow us to meet tight project timelines, I need to bring in additional resource to assist with the workload.

Skills/resource requirement:

Must be on site - We have a paper based Quality system which limits off site working

Interaction with Rob and SME (subject matter experts) to perform Data Integrity assessments on each system.

Document remedial actions including CSV (computer system validation) gaps.

Draft test scripts based on gaps identified during assessments.

Worked in a FDA/MHRA regulated environment (CFR21 Part11a compliance).

Experience with computerized systems in a regulated environment.

Must be willing to work with current Quality systems and existing templates.

If you have the desired experience then please apply with your CV or contact the Nottingham office on 0115 948 5780.

Adecco acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Adecco Group UK & Ireland is an Equal Opportunities Employer.

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Please apply with your CV to: Josh Smith