Posted 3 months ago
Quality Compliance Section Head
AI Summary
Leads the Quality Compliance Section at Eva Pharma in Giza, overseeing deviation management, change control, product quality reviews, internal audits, CAPA effectiveness, and GMP compliance.
About this role
Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members.
Job Summary
We are seeking a passionate and talented Quality Compliance Section Head to join our dynamic team.
The ideal candidate will contribute to our mission of enhancing human health and well-being, ensuring that we meet the highest standards of excellence in our industry.
Key Responsibilities:
• Manage the site's deviation system, ensuring timely investigation, root cause analysis, and closure of quality events.
• Oversee change control activities, ensuring all changes are properly assessed, approved, and implemented in compliance with GMP requirements.
• Coordinate and review annual Product Quality Reviews (PQRs), analyze quality trends, and support continuous improvement initiatives.
• Manage internal audits, support regulatory and customer inspections, and ensure timely closure of audit observations.
• Review, monitor, and verify the effectiveness of CAPAs resulting from deviations, audits, complaints, and quality reviews.
• Monitor quality compliance KPIs and prepare periodic reports for management.
• Ensure GMP compliance across site operations and support inspection readiness activities.
• Coach and support team members while promoting a strong quality culture across the site.
Requirements
• Bachelor's degree in Pharmacy.
• 6–8 years of experience in Pharmaceutical Quality Assurance.
• Previous experience in Quality Compliance, including deviations, change controls, audits, CAPAs, and PQRs.
• Strong knowledge of GMP requirements and pharmaceutical quality systems.
• Experience in handling regulatory inspections and audit activities is preferred.
• Strong analytical, communication, and problem-solving skills.
Skills
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