Job Specification for 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 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 espond 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 the regulatory and compliance requirements and mitigate IT and compliance (GxP, Sarbanes-Oxley, Privacy) risks. Applies critical thinking to right size the governance approach based on risk.
• Facilitate the identification, recording and mitigation of Tech owned risks and non-conformances. Approves non-conformances and exceptions within their 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 related field.

• SAP certification or training is a plus.
• Prior experience with large pharmaceutical company will be an added advantage