SAP Compliance & Validation Lead (S/4HANA)

Corden Pharma; Lisboa; Híbrido; EUR 60 000 - 90 000; Tempo integral

Resumo da oferta

CordenPharma is seeking a compliance-focused SAP specialist to safeguard our SAP S/4HANA landscape in a highly regulated pharmaceutical setting. You will contribute to validation activities, maintain data integrity, and ensure adherence to GxP, 21 CFR Part 11 and EU GMP Annex 11.

Working with IT, QA, business process owners and external auditors, you will manage deviations, CAPAs, changes, and prepare internal and health authority inspections, driving continuous improvement and audit readiness

Qualificações

• Degree in Computer Science, Business Informatics, Life Sciences, Pharmacy, or a related field.
• Several years of experience in a regulated environment such as Pharma, Biotech, MedTech, or Chemicals.
• Strong knowledge of SAP ERP / SAP S/4HANA, CSV, GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, Data Integrity.

Responsabilidades

• Manage SAP-related deviations, CAPAs, and changes.
• Coordinate and support Computer System Validation (CSV) activities throughout the system lifecycle.
• Prepare and support internal audits, customer audits, and health authority inspections.
• Drive continuous improvement of compliance processes and governance.

Conhecimentos

Stakeholder management

Fluent English

Audit readiness

Regulatory compliance

Formação académica

Degree in Computer Science, Business Informatics, Life Sciences, Pharmacy, or related field

Ferramentas

SAP ERP / SAP S/4HANA

Descrição da oferta de emprego

CordenPharma is seeking a compliance-focused SAP specialist to safeguard our SAP S/4HANA landscape in a highly regulated pharmaceutical setting. You will contribute to validation activities, maintain data integrity, and ensure adherence to GxP, 21 CFR Part 11 and EU GMP Annex 11.

Working with IT, QA, business process owners and external auditors, you will manage deviations, CAPAs, changes, and prepare internal and health authority inspections, driving continuous improvement and audit readiness