Validation Specialist

Please send the resumes to careers@starkassociatesllc.com or

Contact: +1 848-300-0022

Position : Validation Specialist

Location : Seattle, WA

Duration : Long term

Job Description:

Primary Skill Set:

Validation planning, Review of Validation deliverables, Defect Management, Periodic Reviews, LIMS system hands of experience .

Responsibilities

• Participates in the planning, conduct, and evaluation of software testing for a complex enterprise-level business solution.

• Must have experience on testing the Patient information integrated into a single system, decreasing the turnaround time for processing, releasing of tests and samples.

• Experience on Validating the Reports for LIMS.

• 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.