General ResponsibilityThe Quality Auditor will report to Global Audit Manager and the primary role of this position will be to perform GxP audits globally.Specific Responsibilities- 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.- Plan, lead, conduct, document, and follow-up of GxP audit according to the requirements specified in the respective the company Quality procedures as well as applicable regulations, standards, quality agreements, and guidance documents.- In case needed, responsible for 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 the company Quality procedures and timelines.- Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to the company Quality procedures on Management of 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 GxP compliance consultant for GxP trainings, task forces, continuous improvement projects as needed.- Review and advise on relevant policies and procedures.- Mentor junior 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 other auditors.- Report metrics as request.Requirements and personal skills- Education: Advanced University Degree in Chemistry, Pharmacy, Chemical Engineering or similar.- Languages: Excellent written and oral communication skills in English and knowledge of Spanish will be an asset.- Experience (years/area): A minimum of 3 years’ experience working in an organization regulated by the GMP principles.- Travels: Willingness to travel 70%.- Personal skills: Ability to maintain the objectivity and consistency approach during the audits. Communication skills and ability to create an environment that facilitates communication. Personal integrity.
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