*KINDLY REFER IF YOU HAVE ANY FRIENDS INTERESTED FOR ANY OF THE BELOW
OPENINGS*

*Requirement details:   *

*Job Title: **Validation Specialist*

*Location: Seattle, WA*

*Duration: 12+ Months*



*Primary Skill Set: Validation planning, Review of Validation deliverables,
Defect Management, Periodic Reviews.*



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 to manage 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.


-- 
*Thanks & Regards,*
Sam Thomas

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