Essential Functions • Participate in computer system and vendor audits for review of their Quality Management System, SDLC, including validation, and data integrity controls. • Review CAPA and verification of CAPAs of system and vendor audits. • QA approver for internal validation efforts. • Act as liaison to the business for guidance and consultancy on software validation. • Support health authority audits/inspections for inspection readiness. Requirements • Bachelor’s degree in associated functional disciplines including IT, Data Sciences and others. • Software development familiarity with both Agile and Waterfall methodology. • Minimum 3-5 years' experience in Pharmaceutical industry or similar. • Minimum 1-3 years' experience Vendor / Computerized System Validation (CSV) Auditing experience • Knowledge of regulations governing software validation and development. • Knowledge of GCP/GMP is preferred. • Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently. • Ability to Travel.