QA Compliance Specialist

Roles & Responsibilities :

• GMP Experience.
• Minimum + years in a GMP-regulated biopharmaceutical environment.
• Quality Assurance Experience .
• At least + years specifically in a QA role.
• QA Compliance Knowledge.
• Strong knowledge of QA Compliance systems including.
• Quality Management Review (QMR).
• Annual Product Quality Review (APQR).
• Self-inspections.
• Audit readiness.
• In-depth understanding of FDA / ICH / EU cGMP regulations and guidelines.
• Data Integrity.
• Experience with Data Integrity principles (ALCOA+).