You will lead audits of Providers and Suppliers in order to assess compliance with regulatory requirements and identify Quality Risks related to GMP/GDP.
Important pharmaceutical company.
Audit preparation, conduction and reporting related to GMP/GDP on Suppliers and Partners sites;
Conduct Audit meetings and schedule the events agenda with the involved teams;
Ensure that findings are identified, all potential critical observations are highlighted and escalate to S&OP and Quality Management;
Finalize the report and ensure it is distributed as per company practices;
Set-up audit Follow-Up;
Provide support during Health Authority Inspections as necessary;
Manage performance of audit team during audit engagements;
Work collaboratively with further International QA Operations auditors to ensure consistency in auditing process;
Contribute to analyze internal metrics, identify and characterize issues, determine root causes, and plan improvement activities.
5 to 10 years of experience in GMP/GDP Audits, including knowledge of all relevant regulations within pharmaceutical industry;
Good understanding of business functions and internal controls to assess compliance in audited organizations;
Willingness and ability to identify and investigate areas of potential risk;
A permanent role within an international environment.
Michael Page SwitzerlandViola Mammola
Bleicherweg 108002 Zürich
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