CSV Specialist

Key repsonsibilities:

Validation Strategy and Management:
Develop and maintain the validation strategy for computerized systems in line with GMP standards such as ISPE GAMP 5, 21 CFR Part 11, and Eudralex Volume 4 Annex 11. Ensure comprehensive management of validation activities to support regulatory compliance.

Execution of Validation Activities:
Execute validation processes, including planning, testing, and documenting validations for computerized systems to ensure they are fit for their intended use and comply with all relevant regulatory requirements.

Continuous Improvement of CSV Processes:
Continuously review and improve CSV processes and procedures to enhance their effectiveness and efficiency. Implement best practices to streamline validation activities and ensure ongoing compliance with GMP standards.

Leadership in CSV Activities:
Lead or consult on CSV activities within IT/OT automation projects an...