Auditor is a highly experienced Quality Director and Qualified Person in the life sciences industry, specializing in GxP compliance across pharmaceuticals, medical devices, cosmetics, and food supplements. With over three decades of expertise, she has led critical projects, including plant construction, quality system remediation, and regulatory compliance. She is an Authorized Qualified Person for pharmaceuticals in the EU and a Responsible Person for Regulatory Compliance under EU MDR 2017/745. Her extensive knowledge spans various regulations, analytical techniques, risk assessments, and certifications, making her a valuable asset in ensuring product quality and compliance. Fluent in multiple languages, she has a strong track record of conducting audits, training teams, and driving continuous improvement.
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