About the job

CSV Specialist

Runcorn, Cheshire

Monday–Friday Day’s  

£50,000

 

Preparation and support execution of validation protocols according to the Validation masterplans and schedule in Computer Systems Validation. Support improvement projects with technical input and participating in problem solving teams.

 

Skills, Experience, and Education Required

 

  • Minimum degree level qualification in relevant life science or equivalent.
  • Good knowledge of current GMP requirements for validation in the EU
  • Good communication skills

 

Key Responsibilities and Duties

 

  • Coach the implementation teams in the proper execution of validation documents
  • Evaluate proposed changes to validated computer systems and recommend level of validation activities required
  • Coordinate audits of internal computer systems validation activities, protocol, and procedures, and prepare responses
  • Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology
  • Develop CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan
  • Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans
  • Act as a CSV Lead for all validation projects
  • Execute or oversee the execution of validation plans and validation documents
  • Perform project management activities for CSV process within the scope of an overall system project
  • Work with overall project manager to include validation activities in implementation timelines
  • Manage internal CSV resources to facilitate completion of qualification activities
  • Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents.
  • Work closely with Validation Manager and QA Compliance to ensure appropriate validation of cGMP computer systems
  • Conduct or facilitate validation and 21 CFR Part 11 training

 

The Company

This company is currently going through a period of growth and about to go on a really exciting journey, there is lots of potential at this business and I would highly recommend applying for this role!

FoodH

 

The UK has now left the European Union. Any EU, EEA or Swiss citizens living in the UK that wish to remain in the UK post Brexit need to apply to the EU Settlement Scheme. Although the closing date for applications was 30th Jun 2021, if you have not yet applied but believe that you would qualify under the EU Settlement Scheme, the Home Office have confirmed that they will consider late applications. For further information please see https://www.gov.uk/browse/visas-immigration/eu-eea-swiss
Many Thanks


« Back