General Responsibility
The Quality Auditor will report to the 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 audits according to the requirements specified in the respective 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 requested.
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 objectivity and consistency during audits.
Communication skills and ability to create an environment that facilitates communication.
Personal integrity.
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