Quality Assurance GMP Italy
Pubblicato il 19-10-2026 - Resourcing Life Science in Italia
Your responsibilities
- Maintain compliance with GMP requirements and applicable quality regulations across manufacturing processes and finished products.
- Review, develop and update SOPs, work instructions and quality documentation, ensuring these are followed consistently in daily operations.
- Assess production and batch documentation for accuracy and compliance, taking appropriate action when products do not meet release requirements.
- Investigate quality incidents and deviations, work with relevant departments to identify root causes, and ensure corrective and preventive actions are implemented effectively.
- Manage customer complaints, oversee investigations and coordinate the implementation of appropriate CAPAs.
- Plan and perform internal audits, document findings and ensure agreed improvements are completed.
- Coordinate external audits and inspections by customers and regulatory authorities, including preparation, responses and follow-up activities.
- Compile annual product quality reviews,
assess quality system performance and prepare required reports and management information.
- Support quality-related discussions with internal teams and external partners, including the preparation and review of quality agreements.
- Advise production teams on quality requirements, promote GMP awareness and encourage a strong quality culture throughout the organization.
- Identify opportunities to improve Quality Assurance processes, monitor relevant KPIs and contribute to departmental performance reporting.
Your profile
- A bachelor’s or master’s degree in a relevant scientific or technical discipline.
- At least five years of Quality Assurance experience / GMP-regulated environment in pharma / biotech
- Practical knowledge of GMP requirements, audit processes, deviation management and CAPA system