About this opportunity
Viatris lists this Site Self Inspection Lead, Quality Assurance - 1st Shift opportunity in town of vermont, Wisconsin. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Role
Site Self Inspection Lead responsible for developing, executing, and tracking site self-inspection plans to ensure regulatory compliance and continuous improvement.
Responsibilities
lead and participate in internal inspections, oversee CAPA development and verification, prepare trend reports, support site audit readiness, and conduct external audits of third-party suppliers; provide training on GMP and inspection processes; support quality culture initiatives.
Requirements
Bachelor's degree in Science, Engineering, or related field; minimum 10 years' experience in GXP settings with extensive knowledge of pharmaceutical cGMP, global regulations (FDA, EMA, WHO, ICH, ISO 9001), and quality systems.
HighValue
HighValue: pharma manufacturing, GxP compliance, cGMP, site audit readiness, global regulations, quality assurance, external and internal inspections, CAPA management.
WorkSetup
not specified; requires in-depth regulatory and quality expertise.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.