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Validation Specialist
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kumar s
Jun 13, 2019, 3:08:08 PM6/13/19
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Hi,
Validation Specialist
Location : Summit, NJ
Rate : Market
Long term Contract
Primary Skill Set
Validation planning, Review of Validation deliverables, Defect Management, Periodic Reviews.
Secondary Skill Set
N/A
Roles and Responsibilities
o Understanding of the purpose of validation.
o Understanding of the overall validation approach for a project.
o Understanding of IT processes and the lifecycle of IT systems.
o Advanced knowledge of all IT process interactions.
o Advanced knowledge of information technology areas and IT service principles.
o Familiarity with FDA regulations (such as 21 CFR 11), GxP, SOX, EudraLex (such as Annex 11), PIC/S, including electronic records and electronic signatures.
o Strong working knowledge of good documentation practices.
o Familiarity with testing and defect management tools such as HP ALM.
o Knowledge of computer network and system security principles.
o Knowledge of IT infrastructure principles.
o Experience in Validation functions in regulated or controlled environments.
o Experience in IT QA functions in regulated or controlled environments.
o Experience in the oversight of computer systems validation strategies and general IT quality assurance.
o Experience in the creation and execution of infrastructure qualification strategies.
o Experience with IT internal audit or periodic review, authoring audit reports or periodic review reports.
o Ability to manage relationships with internal/external teams within the IT organization.
o Experience working with controlled documentation systems.
o Experience of working in an ITIL setting, knowledge of ITIL practices.
Validation Specialist
Location : Summit, NJ
Rate : Market
Long term Contract
Primary Skill Set
Validation planning, Review of Validation deliverables, Defect Management, Periodic Reviews.
Secondary Skill Set
N/A
Roles and Responsibilities
o Understanding of the purpose of validation.
o Understanding of the overall validation approach for a project.
o Understanding of IT processes and the lifecycle of IT systems.
o Advanced knowledge of all IT process interactions.
o Advanced knowledge of information technology areas and IT service principles.
o Familiarity with FDA regulations (such as 21 CFR 11), GxP, SOX, EudraLex (such as Annex 11), PIC/S, including electronic records and electronic signatures.
o Strong working knowledge of good documentation practices.
o Familiarity with testing and defect management tools such as HP ALM.
o Knowledge of computer network and system security principles.
o Knowledge of IT infrastructure principles.
o Experience in Validation functions in regulated or controlled environments.
o Experience in IT QA functions in regulated or controlled environments.
o Experience in the oversight of computer systems validation strategies and general IT quality assurance.
o Experience in the creation and execution of infrastructure qualification strategies.
o Experience with IT internal audit or periodic review, authoring audit reports or periodic review reports.
o Ability to manage relationships with internal/external teams within the IT organization.
o Experience working with controlled documentation systems.
o Experience of working in an ITIL setting, knowledge of ITIL practices.
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