QA GMP Senior Auditor

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8n1z7y

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 Knowledge of GMP requirements Knowledge of auditing techniques Knowledge of sterility assurance principles and GMP expectations for sterile and biotech products Leadership Organisational skills Stress management Knowledge of GMP requirements Auditing techniques Sterility assurance principles

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8n1z7y