Quality Compliance Section Head

Responsibilities

• Manage the site's deviation system, ensuring timely investigation, root cause analysis, and closure of quality events
• Oversee change control activities to ensure all changes are properly assessed, approved, and implemented in compliance with GMP
• Coordinate and review annual Product Quality Reviews (PQRs) and analyze quality trends
• Manage internal audits and support regulatory and customer inspections to ensure timely closure of 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
• Proven experience in Quality Compliance, including deviations, change controls, audits, CAPAs, and PQRs
• Strong knowledge of GMP requirements and pharmaceutical quality systems
• Strong analytical, communication, and problem-solving skills

Preferred Qualifications

• Experience handling regulatory inspections and audit activities

About the Company

EVA Pharma is 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.