Support SAP implementation, change control, and validation activities in a regulated environment, ensuring compliance with GxP, data integrity, and maintaining validated SAP systems used in manufacturing and quality operations.
Key Responsibilities
* Provide SAP GRC expertise (ECC / S/4HANA)
* Support SAP CSV documentation aligned with DTMS and ERP methodology
* Execute system testing, UAT, and regression testing
* Ensure compliance with SOX, Privacy, and GxP requirements
* Support data migration and master data validation
* Assist with audits and address SAP-related findings
* Identify and mitigate technology risks and non-conformances
* Maintain validated state of SAP systems
* Collaborate with cross-functional teams
Mandatory Skills
* SAP experience in pharmaceutical / regulated industry
* Strong IT Quality & CSV knowledge (GAMP5)
* Validation and quality documentation experience
* Data integrity & 21 CFR Part 11 understanding
* SDLC and risk-based validation knowledge
* Infrastructure / Cloud computing understanding
* Excellent communication skills