SAP Computer Systems Validation (CSV) Consultant

We are seeking a CSV Consultant (Computer Systems Validation Expert) to support validation activities in regulated industries such as pharmaceuticals, medical devices, and biotechnology. The ideal candidate will be an experienced professional with a strong command of FDA 21 CFR Part 11, GAMP 5, and GxP requirements.

This role involves the full lifecycle of validation - from planning and writing detailed validation protocols to executing tests, documenting outcomes, and ensuring systems maintain data integrity and regulatory compliance., * Plan, write, and review validation protocols and related documentation for computer systems.

• Draft and maintain test scripts, IQ/OQ/PQ protocols, and validation reports.
• Conduct and document testing activities to verify systems function as intended and meet all regulatory and business requirements.
• Ensure data integrity and adherence to FDA 21 CFR Part 11, GAMP 5, and GxP standards.
• Collaborate with Quality Assurance, IT, and Regulatory Affairs teams to maintain compliance and support internal and external audits.
• Develop and maintain validation documentation, including validation plans, specifications, standard operating procedures (SOPs), and risk assessments.
• Support continuous improvement in validation and documentation processes.

• Proven experience in Computer Systems Validation (CSV) within regulated industries.
• Strong technical writing skills, especially in protocol development and documentation.
• In-depth understanding of quality assurance, quality control, and software validation.
• Working knowledge of risk management principles and validation methodologies.
• Familiarity with automation tools and electronic systems (preferred but not required).