799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

1. Support the strategic development of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan.

2. Plan, lead, conduct, document, and follow-up of GMP audit according to the requirements specified in the respective Novartis Quality Module as well as applicable regulations, standards, and guidance documents.

3. Provide technical guidance, mentoring, and training on audit activities.

4. Audits include pre-qualification audits, routine GMP surveillance audits (both System Based audits and audit focused on special areas/functions e.g. on Stability Program), for cause audits, and mock inspections at suppliers/contractors.

5. Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing.

6. Prepare audit reports according to NVS requirements and timelines.

7. Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to NVS requirements on Management Escalations and other relevant procedures. Ensure adequate definition and recording of mitigation plans when applicable.

8. Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the Follow-up Responsible Person (FURP) and Auditee (Quality Responsible Person, QARP).

9. Act as GMP compliance consultant for GMP trainings, task forces, continuous improvement projects as needed.

10. Review and advise on relevant policies and procedures.
Novartis Oncologyからの続きを読む
RA CMC Manager Japan
Novartis Oncology 5日前
Lab Supervisor , Sasayama
Novartis Oncology 2日前

Global GMP Senior Auditor

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