SAP Compliance & Validation Lead (Hybrid)

Corden Pharma - A Full-Service CDMO; Lisboa; Híbrido; EUR 60 000 - 90 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Employee Events

Positive work culture

Hybrid work

Resumo da oferta

CordenPharma is seeking a compliance and SAP specialist to maintain and validate our SAP S/4HANA landscape in a highly regulated pharma environment. You will collaborate with IT, QA, and process owners to ensure audit readiness and data integrity across systems.

Key tasks include managing deviations, CAPAs, changes, and CSV activities, supporting internal and external audits, and driving governance improvements within change management processes. Fluent English required.

Qualificações

• Degree in Computer Science, Business Informatics, Life Sciences, Pharmacy, or related field.
• Several years of experience in a regulated environment (Pharma/Biotech/MedTech/Chemicals).
• Strong knowledge of SAP ERP / SAP S/4HANA and CSV.
• Familiarity with GAMP 5 and FDA 21 CFR Part 11.
• Understanding EU GMP Annex 11 and Data Integrity requirements.
• Experience with audit readiness, CAPA, deviation, and change management.
• Strong stakeholder management and communication skills; fluent English.

Responsabilidades

• Ensure compliance of SAP S/4HANA and connected applications with GxP, FDA 21 CFR Part 11, EU GMP Annex 11, and Data Integrity.
• 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.
• Ensure compliance within SAP change and release management processes.
• Drive continuous improvement of compliance processes, controls, and governance.
• Act as a trusted partner between IT, QA, and the Business.

Conhecimentos

Regulated environment experience

Stakeholder management

Communication skills

Fluent English

Formação académica

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

Ferramentas

SAP ERP / SAP S/4HANA

CSV

GAMP 5

FDA 21 CFR Part 11

EU GMP Annex 11

Data Integrity

Descrição da oferta de emprego

CordenPharma is seeking a compliance and SAP specialist to maintain and validate our SAP S/4HANA landscape in a highly regulated pharma environment. You will collaborate with IT, QA, and process owners to ensure audit readiness and data integrity across systems.

Key tasks include managing deviations, CAPAs, changes, and CSV activities, supporting internal and external audits, and driving governance improvements within change management processes. Fluent English required.