Job description
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.
• 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.
This job post has been translated by AI and may contain minor differences or errors.
