Sr. System Analyst, Enterprise Apps, Tech Ops

GxP Documentation & Quality System Management

• Documentation Authoring: Lead the development, review, and maintenance of all GxP-critical documentation, including Standard Operating Procedures (SOPs), Work Instructions (WIs), and associated policy documents for SAP system usage and support.

• Requirements & Design: Collaborate directly with business users to finalize User Requirements Specifications (URS) and translate them into detailed Functional Specifications (FS) for system changes, ensuring traceability to testing protocols.

• Audit Support: Maintain the document repository to ensure all validation and change records are complete, accurate, and readily available for internal and external regulatory inspections (e.g., FDA, EMA).

Change Control & Execution Leadership

• Change Management Process: Lead the change control process for all SAP system modifications (implementations, upgrades, config changes, system enhancements) from inception to deployment.

• Impact Assessment: Conduct thorough Impact Assessments for all proposed GxP system changes to identify potential risks to the validated state, data integrity, and regulatory compliance.

• Change Control Board (CCB): Participate the Change Control Board (CCB) process, facilitating meetings, documenting decisions, and ensuring necessary functional and QA approvals are obtained before implementation.

• Execution & Coordination: Assist with the generation of change requests, lead the actual Change Execution in the system, and coordinate technical and functional teams to ensure timely and compliant implementation.

Testing, Validation & Compliance Execution

• Test Documentation: Prepare and maintain comprehensive Test Documentation, including creation of detailed test scripts (IQ/OQ/PQ) and traceability matrices, ensuring alignment with URS and FS.

• Test Execution: Lead and perform the execution of validation testing (IQ, OQ, PQ) and coordinate integration and system-level tests, ensuring all results and deviations are properly documented and resolved.

• Compliance Expertise: Support GxP applications and systems, ensuring adherence to regulatory standards such as GAMP 5, 21 CFR Part 11 (Electronic Records and Signatures), Computer System Validation (CSV) principles, and evolving guidance from regulatory bodies.

Collaboration & SAP Functional Support

• Stakeholder Liaison: Act as the primary liaison between IT functional teams, Quality Assurance (QA), and key business process owners (Manufacturing, Quality, Supply Chain) to facilitate smooth change implementation.

• Configuration Support: Provide functional support by assisting in the configuration and customization of SAP S/4
  
  HANA modules relevant to pharmaceutical operations (e.g., QM, PP, MM, SD).

• System Improvement: Propose alternate processes and procedures to streamline IT operations, increase efficiency, and ensure systems are optimized while remaining compliant.