Validation Specialist

Please share the resumes to careers@starkassociatesllc.com or

Contact: +1 848-219-9146

Position: Validation Specialist

Location: Seattle, WA

Duration: 6+ months Contract

Job Description:

· 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.