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This range is provided by Green Key Resources. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$55.00/hr - $57.00/hr
Summary
The Software Validation Quality Consultant will work closely with the clinical quality assurance systems lead to deliver on internal validation efforts and audits of Client's vendors and computerized systems.
Duties
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.