Senior Technical Lead

Job Description (Posting).

New Billing, Exclusive, CommittedSkills- Computer System Validation, Clinical systems, SAP ECCS4 HANA validationJD- Keywords CSV, Computer System Validation, AP ECCS4 HANA validation, SolmanChaRM Change management, Roles and Responsibilities 7 - 10 years Experience in the Validating IT software systems involved in CAR-T supply chain systems - ERP, SAP, Packaging systems, Warehouse, Logistics etc. in Life Sciences industry ManagerExpert has experience of leadingadvising Junior and Senior resources; has certifications in premierrecognized certifications in their respective areas of expertise

Understanding of CAR-T supply chain process and experience in validating CAR-T related supply chain systems

Experience in FDA andor Global regulated environment with good understanding of GxP standards and Risk based validation. Experience in validating Global Risk and Compliance modules

Provides consultation and counseling on Risk and Compliance module implementation in reference to regulatory quality

Knowledge of FDA guidance s and industry standards

Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliancevalidation Plans, test protocols, Test Summary reports and ComplianceValidation Reports )Experience in reviewing system test and user acceptance test scripts, Traceability matrix related to System data Archival process

Hands-on experience in software life-cycle management in System data archival process Ability to provide Validation guidance, timely reviews, and escalations to Project teams