GCP/PV Compliance Specialist
hace 14 horas
About the Role:
">We are seeking a GCP/PV Auditor to join our team at ES06 (FCRS = ES006) Novartis Farmacéutica, S.A. The ideal candidate will have 5 years of experience in GCP/GPvP/clinical/industry/health authority and be fluent in English.
">Key Responsibilities:
">- Plan, lead, conduct, document, report, and follow up on GCP/PV audits according to Novartis procedures and applicable regulations, standards, quality agreements, and guidance.
- Perform low-risk GCP/PV activities such as Investigator site audits, single service vendors, systems/process, Patient Oriented Programs, etc.
- Provide technical guidance and training on audit activities.
- Escalate critical audit findings and support immediate follow-up measures.
- Maintain current knowledge of regulations, standards, and guidance documents.
Requirements:
">- Degree in natural/biological sciences or equivalent.
- 5 years GCP/GPvP/clinical/industry/health authority experience or equivalent (1-2 years of GCP/PV auditing experience preferred).
- Thorough knowledge of applicable GCP, GPvP and GxP regulations, guidelines, policies, and procedures.
- Ability to manage and objectively evaluate compliance issues.
Why Work with Us:
">Our purpose is to reimagine medicine to improve and extend people's lives. We value diversity and inclusion in our workplace.
">Estimated Salary: €65,000 - €90,000 per annum, depending on location and experience.
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