Overview
Experteer OverviewAs a Qualified Person, you will independently oversee manufacturing processes and batch release in line with regulatory requirements and our GMP quality system. You will collaborate with Quality Control, Production, and site leadership to ensure product quality and regulatory compliance, driving improvements in processes, documentation, and CAPA. You will act as the link with health authorities, reporting significant issues and ensuring transparent lot documentation. Your role supports steady, compliant production and contributes to high-quality medicines for patients. This is an opportunity to influence quality culture and operational excellence in a leading pharmaceutical environment.
Retribuzione / Benefits
- Certify that each batch complies with the marketing authorization and legal requirements
- Assess and release medicinal products per national legislation
- Ensure attestations of lot suitability are available for health authorities
- Collaborate on deviation investigations and approve related actions
- Ensure proper storage of batch release documentation for authorities
- Communicate substantial irregularities to health authorities and management
- Work with Quality Control and Production on batch activities
- Identify and propose improvements to manufacturing processes for quality, productivity and cost
- Collaborate with Function Managers to ensure the Quality Management System is correct
- Manage deviations, complaints, change control and CAPA
Responsabilità
- Degree in Pharmacy, CTF or Chemistry
- Previous experience as Qualified Person in pharmaceutical sterile manufacturing (authorized certificate)
- Strong affinity with quality and quality issue awareness
- Open and clear collaboration and communication to ensure smooth daily operations
- Fluency in Italian and English
