SAP GRC / CSV Specialist (Pharma Domain)
New Yesterday
End Client Domain: Pharma
Location: London, UK
Work Model: 1 2 Days Onsite (Flexible Hybrid)
Contract: Fixed Term (12 months)
Must-Have Domain Experience Pharma, manufacturing experience
Systems validation
SAP GRC (Domain side)
GxP / IT quality
SAP modules exposure FICO, P2P
Solid Infrastructure / Cloud computing knowledge
Purpose of the Role To support SAP implementation, change control, and validation activities within the client environment in accordance with GxP and regulatory requirements. This includes executing Computer System Validation (CSV) tasks, ensuring data integrity, and collaborating with cross-functional teams to maintain validated states of SAP systems used in manufacturing or quality operations. Solid infrastructure and cloud computing knowledge is required.
Job Specification GRC CW with SAP / GxP / Infrastructure (Cloud Computing) Provide subject matter expertise in SAP modules relevant to manufacturing, quality, or supply chain.
Support and maintain CSV documentation, including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, and traceability matrices.
SAP system testing, UAT, and regression testing as required.
Solid understanding of Cloud Computing and Infrastructure.
Ensure compliance with GMP, GAMP5, MHRA/FDA regulations during system changes or implementations via client DTMS.
Collaborate with QA, IT, manufacturing, and engineering to implement and validate SAP changes.
Support data migration, master data validation, and system configuration reviews.
Assist in audit preparation and respond to any CSV/SAP-related findings.
Key Responsibilities Provide subject matter expertise in SAP (ECC / S/4HANA) modules relevant to manufacturing, quality, or supply chain.
Support and maintain CSV documentation, including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, and traceability matrices.
Coordinate and execute SAP system testing, UAT, and regression testing as required.
Ensure compliance with GMP, GAMP5, MHRA/FDA regulations during system changes or implementations.
Collaborate with QA, IT, manufacturing, and engineering to implement and validate SAP changes.
Support data migration, master data validation, and system configuration reviews.
Assist in audit preparation and respond to any CSV/SAP-related findings.
Work with external vendors and internal stakeholders to deliver compliant and timely system updates.
Support SAP/S4 implementation to fulfil regulatory and compliance requirements and mitigate IT and compliance (GxP, Sarbanes-Oxley, Privacy) risks. Apply critical thinking to right-size the governance approach based on risk.
Facilitate the identification, recording, and mitigation of Tech-owned risks and non-conformances. Approve non-conformances and exceptions within area of responsibility.
Mandatory Requirements Experience with SAP in a pharmaceutical or regulated industry (modules like MM, PP, QM, WM, etc.).
Strong knowledge of CSV principles, including GAMP5 and ALCOA+ principles.
Proven experience in validating SAP enterprise systems in GxP environments.
Experience authoring and reviewing validation documentation.
Understanding of data integrity and 21 CFR Part 11 requirements.
Familiarity with SDLC (System Development Life Cycle) and risk-based validation.
Solid Infrastructure / Cloud computing knowledge required.
Excellent written and verbal communication skills.
Optional / Nice-to-Have Requirements Bachelor's degree in IT, Engineering, Life Sciences, or a related field.
SAP certification or training is a plus.
Prior experience in a large pharmaceutical company.
TPBN1_UKTJ
- Location:
- Sheffield
- Salary:
- not provided
- Job Type:
- FullTime
- Category:
- IT;Finance;Consulting