Paul Kalejta

Validation Lead @Tata Consultancy Services

Philadelphia, PA, US

EMAILS

[email protected]

MOBILE NUMBERS

+91 *********19

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WORK HISTORY

Apr 2024 — Present

Validation Lead @Tata Consultancy Services

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Boyertown, PA, US

Brought onboard as remote Validation Lead at a major biopharm client with 3 months to go in a LabVantage LIMS validation project (Instruments, Consumables, Lab Execution System modules). Managed an off-shore team in authoring and executing in ALM 40+ OQ scripts (manual and automated) and 50+User Acceptance scripts. Identified and managed defects (including 7 system configuration issues), generated an automated Trace Matrix from ALM, and authored and gained all approvals on the final Summary Report. System went live on 03-July-2024, one day past the target date.

EDUCATION

N/A

Penn State University

Bachelor of Science - BS

N/A

Pottstown High School

High School Diploma

SKILLS

Corrective and Preventive Action (Capa)21 Cfr Part 11Laboratory AutomationGxpQuality AssuranceData IntegrityGmpPharmaceuticalsQuality CenterChromatographyPharmaceutical IndustrySopFdaHp Quality CenterChange ManagementComputer System ValidationSoftware DocumentationSdlcR&DU.s. Food and Drug Administration (Fda)GampU.s. Title 21 Cfr Part 11 RegulationGas ChromatographyDocumentationUv/VisLaboratoryChange ControlLimsCapaComplianceValidationLaboratory Information Management System (Lims)

ABOUT PAUL KALEJTA

Keeping my Clients in GMP Compliance” I am driven to use my years of experience in…

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