*QA Validation Lead
Location: Westlake Village, CA
Duration: 6+ month contract position
*

Here is the job description for Baxter's new Validation Lead role in
Westlake Village, CA.
JOB DESCRIPTION
Expected duration is 6 months and could be extended based on project need

• Creating validation deliverables in line with the Baxter Corporate
Quality Procedure guidance.
• Ensuring the validation approach for IT systems is done in a harmonized
and standardized fashion. Develop templates and stream line processes.
• Optimizing the validation approach for IT systems used in Serialization
and e-pedigree project. Oversee and co-ordinate the validation
deliverables/execution at local manufacturing sites.
• Assuring, in association with the project QSR, that a system/application
meets its requirements and is compliant with applicable Baxter QMS
documents, and the documentation set outlined in the Validation Plan for
the project.
• Supporting a CSO and QSR in all GxP regulations, compliance with internal
and external procedures, and all aspects of safe, reliable, and consistent
operation of the computerized system.
• Reviewing validation life cycle documentation from validation
function/SME perspective for Supply Chain Security portfolio projects.
• Perform Risk Assessment, Quality Assessment and 21 CFR assessment for IT
systems.
• Ensuring adequate procedures are in place for computerized systems
implementation, use, and support

-------------------------------------------------------------------------------------------------------------------------------------------------------
Warm Regards,
Alvin Paul | Accounts Manager
Panzer Solutions LLC | 360 Connecticut Ave,
Suite # 159,Norwalk CT 06854
alvin.p...@panzersolutions.com
www.panzersolutions.com
203-652-1444 Ext: 159 | Direct: 203-208-9064

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