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Job Description

Validation Specialist

Expires on: December, 3 2019
Job Code: VL/SK/0309/D/07
Hyderabad
Experience: 8-10 Years
Location: Hyderabad

We are looking for a Validation Specialist

Responsibilities
  • Understanding of the purpose of validation.
  • Understanding of the overall validation approach for a project.
  • Understanding of IT processes and the lifecycle of IT systems.
  • Advanced knowledge of all IT process interactions.
  • Advanced knowledge of information technology areas and IT service principles.
  • Familiarity with FDA regulations (such as 21 CFR 11), GxP, SOX, EudraLex (such as Annex 11), PIC/S, including electronic records and electronic signatures.
  • Strong working knowledge of good documentation practices.
  • Familiarity with testing and defect management tools such as HP ALM.
  • Knowledge of computer network and system security principles.
  • Knowledge of IT infrastructure principles.
  • Experience in Validation functions in regulated or controlled environments.
  • Experience in IT QA functions in regulated or controlled environments.
  • Experience in the oversight of computer systems validation strategies and general IT quality assurance.
  • Experience in the creation and execution of infrastructure qualification strategies.
  • Experience with IT internal audit or periodic review, authoring audit reports or periodic review reports.
  • Ability tmanage relationships with internal/external teams within the IT organization.
  • Experience working with controlled documentation systems.
  • Experience of working in an ITIL setting, knowledge of ITIL practices.
Requirements
  • Validation planning.
  • Review of Validation deliverable, Defect Management, Periodic Reviews.
  • Familiarity with FDA regulations (such as 21 CFR 11), GxP, SOX, EudraLex (such as Annex 11), PIC/S, including electronic records and electronic signatures.
  • Familiarity with testing and defect management tools such as HP ALM.




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