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Computer Systems Validation Engineer

I7587D

Computer Systems Validation Engineer required for a Dublin based Pharmaceutical organisation.

Category:
Automation
Location:
Leinster
Years of Experience Req.:
3 years+
Date Posted:
03/06/2019
Days Remaining:
41
Employment Type:
Contract
Education Level Req.:
Third Level Degree

Computer Systems Validation Engineer                                            

DPS currently require a Computer Systems Validation Engineer for a Dublin based Pharamceutical organisation. 

Resonsbilities:

  • Manage, co-ordinate, develop and execute the validation deliverables for new Information System (IS) projects.
  • Support and co-ordinate the qualification and validation processes.
  • Support activities include, but are not limited to; the preparation of Validation/Qualification Plans, Risk Assessments, User Requirement Specification, Traceability Matrix, Testing (IQ, OQ/PQ), Data Migration, SOPs and Change controls.
  • Responsible for ensuring that computeriz537304.322006ed systems are in full compliance with regulatory requirements, company policies and procedures. 
  • This individual will provide compliance leadership, direction and execution in Computer System Validation for new projects.
  • Support the resolution of project deviations/errors and provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11.)
  • Participate in required project teams.

 

 Requirements: 

  • A minimum of a Bachelor’s degree with a minimum of 3 years of related CSV industry experience (Pharma/Biotech).
  • Validation experience with ERP, MES, LIMS, and Quality Systems is preferred.
  • Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11 is required.
  • Strong knowledge of computeriz537304.322006ed system development life cycle approach is required.
  • Experience of coordination of Quality documentation and in particular, qualification/Validation documentation.

 

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