CSV Consultant - Freelancer

Engaging Senior CSV Professionals (Contract Basis) – India As regulatory expectations around digital systems continue to tighten, we are expanding our Computer System Validation (CSV) capability for upcoming GMP programs. We are looking to engage experienced CSV professionals (contract basis) who can independently drive end-to-end validation programs for regulated pharmaceutical environments. What We Are Looking For Professionals who can lead and execute the complete lifecycle of Risk-Based Compliance Assessments, including risk identification, risk mitigation, and reporting. The ideal candidate will have experience in CSV, GAMP5, and/or 21 CFR Part 11. Key Responsibilities: • Develop and execute comprehensive validation plans for computerized systems, including requirements gathering, testing, and documentation. • Conduct thorough reviews of system designs, specifications, and test protocols to ensure compliance with regulatory requirements. • Collaborate with cross-functional teams to identify and mitigate risks associated with computerized systems. • Provide expert-level guidance on CSV best practices, GAMP5, and 21 CFR Part 11. • Develop and maintain documentation for validation activities, including reports, procedures, and records. What We Offer Competitive compensation package, including hourly rate and benefits. Opportunities for professional growth and development in a dynamic industry. Collaborative work environment with experienced professionals. Flexible working arrangements to suit your needs.