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COMPUTER VALIDATION SPECIALIST

 

Company:

KEY2 RECRUITMENT
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Job Reference Number

14562389

Client ID:

RI/2342
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Posted On:

Jan 26 2012

Location:

GALWAY , CORK, LIMERICK
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Job Type:

Contract/Permanent

Salary:

NEGOTIABLE
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Benefits:
  • PENSION / PRSA
  • BONUS
  • VHI
Computer Validation Specialist

Key 2 Recruitment have been retained by an expanding healthcare organization based in Limerick to recruit a Computer Validation Specialist for a 12 month contract

Responsibilities:

  • Co-ordination, implementation and active participation in the IT validation program.
  • Develop validation documentation as required (e.g. specifications, plans, protocols, procedures etc.).
  • Execute, and report on, qualification protocols.
  • Resolve and assist in the closure of deviations.
  • Manage the IQ ,PQ, OQ process
  • Co-ordinate re-validation activities
  • Generate SOP's / other documentation as applicable
  • Present validation systems at external audits
  • Support quality assurance programmes
  • Provide input into all product development project phases i.e. from design through to the commissioning and qualification execution phases of the project.
  • Conduct validation activities in compliance with US and EU regulations, global procedures and EHS requirements.
Requirements:

  • Relevant 3rd Level Qualification in science or engineering
  • IT validation experience in an established QA function preferably in the healthcare industry
  • knowledge of CSV/GAMP, 21CFR Part 11, cGMP Regulations advantageous
  • Strong statistical skills and process capability are required along with excellent interpersonal, communication, facilitation and team working skills.
Salaries have been at or above market rate and potential for career progression is excellent



For more information on this Computer Validation Specialist position please contact Key 2 Recruitment, email info@ key2recruitment.ie or call 065 6828100