Business Specialist

Hälso- och sjukvård samt biovetenskap · Bioteknik och läkemedel · Klinisk forskning · Läkemedelsutveckling · Bioinformatik

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I korthet

Die Rolle des SAP Validation Analyst ist verantwortlich für die Sicherstellung, dass SAP-Anwendungen und zugehörige Geschäftsprozesse die Anforderungen an Computer System Validation (CSV), GxP, Datenintegrität und regulatorische Konformität erfüllen, insbesondere in den Bereichen Pharmazie, Biotechnologie und Medizintechnik. Die Rolle unterstützt SAP-Implementierungen, Upgrades, Erweiterungen und Änderungskontrollen durch risikobasierte Validierung, Tests und Dokumentation.

Ansvarsområden

Perform SAP system validation for implementations, upgrades, configuration changes, and enhancements.
Prepare/review validation documentation such as Validation Plans, URS, Functional/Design Specifications, IQ/OQ/PQ, Traceability Matrix, test protocols, and validation reports.
Develop and execute test scenarios/scripts and document evidence and results.
Perform risk assessments, deviation management, root-cause analysis, and support corrective actions.
Ensure compliance with GxP, FDA requirements, 21 CFR Part 11, and applicable company quality procedures.
Support change control and validation activities throughout the SAP system lifecycle.
Collaborate with SAP functional teams, technical teams, QA, business stakeholders, and external vendors.
Support regulatory audits and inspections by providing validation documentation and evidence.

Krav

SAP Validation / Computer System Validation (CSV)
GxP compliance
Validation lifecycle documentation
IQ/OQ/PQ
URS and functional/design specifications
Test planning, test execution, and defect management
Requirements Traceability Matrix
Risk assessment and change control
Data integrity and regulatory compliance
Knowledge of 21 CFR Part 11 / GAMP 5 principles
Understanding of SAP business processes and relevant SAP modules
Strong documentation, analytical, and stakeholder-management skills

Önskade kvalifikationer

Experience working on SAP systems in a pharmaceutical, life-sciences, biotechnology, or medical-device regulated environment is particularly relevant.

Förmåner

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Färdigheter

SAP ValidationComputer System Validation (CSV)GxPValidation lifecycle documentationIQ/OQ/PQURSFunctional SpecificationsDesign SpecificationsTest planningTest executionDefect managementRequirements Traceability MatrixRisk assessmentChange controlData integrityRegulatory compliance21 CFR Part 11GAMP 5SAP business processesSAP modulesDocumentationAnalytical skillsStakeholder managementFDA requirements

#SAP#Validation#CSV#GxP#Data Integrity#Regulatory Compliance#Pharmaceutical#Biotechnology#Medical Devices#FDA#21 CFR Part 11#GAMP 5#Risk Assessment#Change Control#Test Execution

Om HCLTech

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HCLTech is a global technology company, home to 219,000+ people across 54 countries, delivering industry-leading capabilities centered around digital, engineering and cloud, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending September 2022 totaled $12.1 billion. To learn how we can supercharge progress for…

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