Opening for Labx Lead/sme - Branchburg, NJ

view the job in browser: Jobboard.aquainsys.com


Title: Labx Lead/sme
Location: Branchburg, NJ


Detail:
Duration: 6 MonthsMandatory Skills: Experience with major LABX implementation performing the role of LABX Lead/SMEJob Description: Act as Validation and Qualification Lead on a large laboratory remediation projects, with specific focus on Laboratory Standalone COTS systems & LabX (Mettler)Author theS typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.Assist systems users with defining, authoring and documenting system use in user, admin, and maintenance SOPsCoordinate alignment of systems users from various company groups on validation and qualification documentationProactively communicate with various company organizations and systems vendors to ensure the project hurdles are overcome quickly and effectivelyProvide tactical guidance and coaching in support of systems testing efforts with the stakeholdersAct as validation task lead: take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, stay proactive, etc.Qualifications:7+ years of Lab Systems validation experience is required.10+ years are desiredMettler LabX deployment, method development and validation experience (end to end) - pH, balance, titrators, refractometers, melting point and density meters; 2+ years’ experience with LabX method development and validation preferred.Specific hands-on experience with validating, qualifying, and/or using Pharmaceutical QC Lab Standalone COTS systems are required, including the authoring end to end of life cycle documents (including systems use and administration procedures)Understanding of Data Integrity concepts is requiredExcellent communication and written skills requiredLeadership skills: guidance, facilitating and team building.Effectively utilize tracking tools: MS Excel, Project, PowerPoint, MS Teams, SharePoint, etc.Trained by Mettler Toledo in LabXProactive tracking and follow up on tasks for self and teamAbility to organize for action and perform

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Thanks and Regards,

Y. PREMKUMAR

Aqua Information Systems Inc.



300 N Pottstown Pike, Suite # 130


Exton, PA 19341


Direct: 215-666-6795


Fax: 215-600-1617



Email:

pyellapu@aquainsys.com





URL:

www.aquainsys.com








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