Erik R.

I ensured ongoing compliance of ERP applications with GxP and GDPR requirements.

CSV Project Manager: responsible for validation strategies and management of relevant IT systems

Preparation and review of CSV documents in accordance with standard operating procedures, laws, and guidelines

I contributed to change management, gap resolution, and CAPA in close collaboration with stakeholders from IT, quality, and commercial departments

I served as subject matter expert (SME) for ERP compliance during internal audits, supplier audits, and health authority inspections.

I supported ERP system validation activities, including validation planning,

requirements gathering, design review, test planning and execution, and validation report writing. I was responsible for writing documentation related to the validation lifecycle and deviation management.

Application of a risk-based methodology, including software assurance concepts (CSA)

Support the development of requirements for the operational phase of the ERP system, including change management, user access review..

• Planned, & Executed all phases for CSV/Oracle ARGUS to CSD, TRM, OQ, PQ/UAT Test Scripts, VSR.

• Prepared, Reviewed & Approved Technical & GCP related Documentation (VP, URS, impact/Risk Assessment).

• Writing Functional Risk Assessment Activities & provide Validation SME for identification of Risks.

• Collaborate on Veeva Validation VP, URS, UAT protocols, UAT Scripts, UAT reports and TRM.

• Reviewed of GCP Documentation & Data for Compliance to applicable Procedures, Regulatory & Corporate Guid ance Documents.

• Redaction of Periodic review.

• Created key CSV deliverables and/or assist business units in writing CSV documentation (e.g. Validation Plan, Func tional Requirements Specification, Test Scripts, Validation Report), based upon approved templates / processes and ensures proper filing in respective Document Management System.

• Reviewed Vendor Validation Documentation & provide documented feedback & Guidance.

• Executed Impact / Risk Analysis & Document respective outcome.

• Supported the analysis & monitoring of security processes & incidents.

• Participate as a "Tester" & Investigate Test Defects, Resolution & Reporting.

• Provide CSV training as appropriate for users of specific systems.

• Applied & Respect internal Procedures & Templates & ensure GMP Validation.

• Closely collaborate with the BO & SO & understand the synergy between Business, Quality & IT.