The Software Validation Quality Consultant will work closely with the clinical quality assurance systems lead to deliver on internal validation efforts and audits of company's vendors and computerized systems.
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.