Quality Compliance Section Head
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.
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.