QA GMP Senior Auditor

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8eed6r

Who we are looking for

This is what you will do

The role supports the execution of first and second party audits, the qualification and maintenance of R&D; suppliers and service providers, and the definition and management of Quality Agreements.
The position includes a dedicated focus on sterile, biological and biotech products.
Experience in gene therapies or related advanced platforms is considered a plus.

You will be responsible for
- Plan and execute second party audits of GMP suppliers and GMP service providers (CMOs , contract laboratories).
- Execute first party audits.
- Monitor the follow-up of audit non-conformities and verify the adequacy and timely closure of corrective and preventive actions.
- Manage and coordinate external consultants supporting the Auditing & Supplier Qualification - GMP & Medical Device Unit.
- Define, review and finalise Quality Agreements with GMP suppliers and service providers.
- Support the hosting of GMP inspections.
- Collect and review data for Management Review and KPIs/ metrics.
- Finalize,



review and standardise SOPs related to auditing and supplier/service providers qualification processes.
- Organise and support training on GMP requirements and related procedures.
- Act as QA reference for audit and qualification activities supplier/service providers involving sterile, biological and biotech products.
- Interact with CMC, Regulatory Affairs, Clinical Supply, Procurement and other cross-functional teams to what concerns qualification of the above listed providers.

You will need to have
- Scientific degree, preferably in Pharmacy, Chemistry, Biology, Biotechnology, Pharmaceutical Sciences or a related scientific discipline.
- At least three years of experience as auditor in pharmaceutical companies.
- Experience in Quality Assurance, supplier qualification or audit activities within pharmaceutical development and/or manufacturing environments.
- Knowledge of GMP requirements
- Knowledge of auditing techniques
- Knowled

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8eed6r