Global Quality Assurance Specialist
hace 4 semanas
In this position, you will be a key part of the Global Auditing team at Advanced Accelerator Applications (Italy) - Spain, building upon and maintaining our exceptional standards. This role comes with a flexible location and we are ready to hire the successful candidate in the city of preference within Spain.
Key Responsibilities- Plan, lead, conduct, document, report, and follow-up of GCP/PV audits: according to Novartis procedures and applicable regulations, standards, quality agreements, and guidance documented.
- Provide technical guidance and training on audit activities: ensuring adequate definition and recording of mitigation plans when applicable.
- Maintain current knowledge of regulations, standards, and guidance documents: assessing the adequacy of responses to audit findings in cooperation with Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP).
This entry-level global auditor role involves conducting low-risk GCP/PV audits, such as Investigator site audits, single service vendors, systems/process, Patient Oriented Programs, etc. The auditor may also assist in supporting complex audits.
Requirements- Degree in natural/biological sciences or equivalent: combined with 5 years of experience in GCP/GPvP/clinical/industry/health authority or equivalent (1-2 years of GCP/PV auditing experience is preferred).
- Thorough knowledge of applicable GCP, GPvP and GxP regulations, guidelines, policies, and procedures: ability to manage and objectively evaluate compliance issues.
- Able to address a variety of tasks within the same timeframe: maintaining oversight; moderate degree of independence with respect to decision making and problem solving.
- Experience with Health Authority inspections and interaction: a plus.
The salary for this position is approximately €60,000 per year. Additionally, you will receive a comprehensive benefits package, including health insurance, retirement plan, and paid time off.
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