Overview
In this role you will support the execution of audits (second and first party), qualify R&D; suppliers, and manage Quality Agreements to ensure GMP compliance for sterile, biological, and biotech products. You will collaborate with cross-functional teams and external consultants to drive quality assurance across supplier networks. The position offers hands-on audits, KPI data review, and SOP standardisation within a performance-driven, global R&D; context. This is a chance to contribute to high-stakes compliance in gene therapies and advanced platforms.
Retribuzione / Benefits
- annual premio
- pension
- private medical insurance
- wellbeing programme
- flexible benefits programme
- relocation support
Responsabilità
- Plan and execute second party audits of GMP suppliers and GMP service providers (CMOs, contract laboratories)
- Execute first party audits
- Monitor corrective and preventive actions and ensure timely closure
- Coordinate external consultants supporting Auditing & Supplier Qualification - GMP & Medical Device Unit
- Define,
review and finalise Quality Agreements with GMP suppliers and service providers
- Support hosting of GMP inspections
- Collect and review data for Management Review and KPIs/metrics
- Finalize and standardise SOPs related to auditing and supplier qualification processes
- Organise and support training on GMP requirements and related procedures
- Act as QA reference for audit and qualification activities involving sterile, biological and biotech products
- Interact with CMC, Regulatory Affairs, Clinical Supply, Procurement and cross-functional teams to qualify providers
Requisiti fondamentali
- Scientific degree, preferably in Pharmacy, Chemistry, Biology, Biotechnology, Pharmaceutical Sciences or related discipline
- At least three years of experience as auditor in pharmaceutical companies
- Experience in Quality Assurance, supplier qualification or audit activities within pharmaceutical development or manufacturing
- Knowle
📌 QA GMP Senior Auditor (Italia)
🏢 Chiesi
📍 Italia