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CSV Engineer

ID
14143
Location
Cork, Ireland
Role Type
Contract
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Title: CSV Engineer
Type: Contract
Location: Cork, Ireland

Overview:

  • Leading Medical Device company based in Cork are looking to hire Contracting CSV Specialists.
  • You will be joining the Pharmaceutical Quality System global team dedicated to the remediation of identified IT infrastructure gaps

Responsibilities:

  • Ensure Regulatory compliance in area of responsibility (Annex 11/15, 21 CFR Part 11, GAMP 5) for GMP pharmaceutical regulatory agencies
  • Facilitate and coordinate resources for the identification, creation, review and approval of IT infrastructure documentation.

Work in conjunction with Global IT Infrastructure teams and site teams to identify, create, review, and approve documentation

  • Collaborate with iQMS and site teams to review and approve documentation.

Requirements:

  • LEAN and Six Sigma philosophy are embedded in your day to day working.
  • Experience in the pharmaceutical industry.
  • Experience working with validation and qualification projects within GMP regulated environments.
  • Solid understanding and hands-on working knowledge of Computer Systems Validation requirements for all aspects of computer systems and infrastructure involved in medicinal product production.

 

For further information on this CSV role in Cork please contact Karl Lippett on it@hero.ie or 086-1070950

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

 

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