GMP QUALITY AUDITOR

General Responsibility The GMP Quality Auditor will report to Global Quality Systems & Compliance Director of Insud Pharma, and the primary role of this position will be to perform GxP Quality audits globally.Specific ResponsibilitiesSupport 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 GMP audits according to the requirements specified in the respective Insud Pharma 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 Insud Pharma Quality procedures and timelines.Collaboration and communication with the sites in terms of updates and executions related with their audits.Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to Insud Pharma 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.Ensure the compliance of all activities and documentation according to the applicable procedures. Act as GMP compliance consultant for GMP trainings, task forces, continuous improvement projects as needed.Review and advise on relevant policies and procedures.Mentor junior GMP staff as required.Follow up of qualification and requalification activities according to the applicable procedures.Maintain current knowledge of regulations, standards, and guidance documents.Identify and report best practices and lessons learned to support development/training of GMP auditors.Report metrics as request Requirements and personal skillsEducation: 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 7-10 years’ experience working in an organization regulated by the GMP principles.Specific Knowledge: Proven experience in a GxP Auditing role. Good knowledge of the EU and FDA regulations that apply to the Research & Development, Manufacturing and Distribution of Pharmaceutical products and their raw materials.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