Supports and assesses quality and compliance processes in healthcare at Grifols. Engaging in audit planning, regulatory inspections, and ensuring adherence to quality standards.
Responsibilities
Supports and assesses activities to ensure adherence to quality and compliance processes
Coordinates with donor centers for external inspections
Aids with audit planning and responses
Responsible for developing and reviewing audit responses / CAPA plans
Ensures compliance with Domestic / European regulations through routine review
Requirements
Bachelor’s Degree Required
5 years of experience
Knowledge of the Code of Federal Regulations (CFR)
Understanding of the European Pharmacopoeia (EP) and other European Guidelines
Ability to write clear, concise, logical responses to regulatory authorities
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