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CSV Lead

PE Global
Job LocationRuncorn
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract, full-time

Job Description

PE Global are recruiting for a CSV Lead contract role with a leading multinational client based in Runcorn.Responsibilities

  • Maintain, develop, implement and monitor site policy and procedures for CSV to ensure that they reflect current industry thinking and are compliant to cGMP, corporate policies & quality standards manual and regulatory guidelines.
  • Perform periodic reviews of computer systems.
  • Assist in the implementation of the site Data Integrity programme.
  • Perform remediation of computer systems.
  • CSV lead for new projects (this includes LabX, Laboratory Monitoring System, building management system, Serialisation, facility monitoring system, various manufacturing and lab systems).
  • Generation of computer validation documents (e.g. Val Plan, Functional Design Specification, IQ, OQ, ERES, DRP).
  • Co-ordination of CSV related activities.
  • Ensure the Computer System Site Inventory is periodically reviewed and kept current.
  • Conduct periodic internal-audits to the implementation.
  • Represent the computer systems validation approach to regulatory authorities during inspection.
    • Requirements
  • Minimum of degree in a relevant discipline.
  • Extensive experience of CSV in a pharmaceutical manufacturing environment. (minimum of 5 years in a lead CSV role).
  • Worked with manufacturing system (i.e. PLC/SCADA), Lab systems and business information system.
  • Specialist knowledge of CSV derived through both practical experience and theoretical studies.
  • Excellent understanding of the regulatory expectations relating to CSV.
  • A broad understanding of validation principles in general and the GMP expectations as applicable.
  • In depth knowledge of GAMP.
  • An understanding of Data Integrity in line with recent regulatory expectations.
    • Interested candidates should submit an updated CVPlease click the link below to apply, call Alba on + or alternatively send an up to date CV***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.

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