Source description
About the role
Please share the profiles to careers@starkassociatesllc.com or
contact:+1 848-300-3555
Job Position: Validation Engineer
Location: North Chicago ,IL
Duration: Contract
Description:
5+ years of specific experience working in reputed pharmaceutical company
Require prior experience in creating Change Requests, Developing Validation Plan, test scripts, Summary Reports, Traceability Matrix and other validation project documents in the Pharmaceutical industry
Sound knowledge on regulatory compliance. One or more of the following areas: CAPA, 21 CFR Part 11, GAMP, GMP, GLP, GCP, GVP, GxP, IQ/OQ/PQ and Computer Systems Validation (CSV)
Create and execute validation test scripts and document test results in accordance with standards (Manually or in HP Quality Center). Review and evaluate validation assessments for application systems/projects.
Ability to manage multiple tasks and projects simultaneously, and to prioritize work, goals and tasks per the divisional and corporate objectives
Strong interpersonal and technical writing skills and the ability to interact across divisional boundaries
Having Information Technology (IT) background with experience in Quality/Regulated environment including SDLC
Ability to report results clearly and concisely. Sound reasoning and ability to quickly analyze and solve complex problems
Experience with HP Quality Center (QC), HP QTP, HP ALM and SharePoint is preferred
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