Support the strategic development of an effective risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan.
Plan, lead, conduct, document, and follow-up of GMP audit according to the requirements specified in the respective Sandoz Quality procedures as well as applicable regulations, standards, quality agreements, and guidance documents.
For this role, auditors will be given more complex and higher-risk audits, such as sterile API, aseptic DP, and combination products. The ability to assess risk of these operations is critical to success.
Provide technical guidance, mentoring, and training on audit activities.
Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing.
Prepare audit reports according to Sandoz requirements and timelines.
Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to Sandoz requirements on Management Escalations and other relevant procedures. Ensure adequate definition and recording of mitigation plans when applicable.
Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the stakeholder QA representative and Auditee.
Act as GMP compliance consultant for GMP trainings, task forces, continuous improvement projects as needed. Assure permanent transfer of best practice identified during the audit into Sandoz QMS system
Review and advise on relevant policies and procedures.
Mentor junior GMP staff as required.
Maintain current knowledge of regulations, standards, and guidance documents.
Identify and report best practices and lessons learned to support development/training of GMP auditors.
