Quality Auditor

Job Description

Key Skills: Audit, Vendor Management, Account Audit. Roles and Responsibilities: Conduct Audits: Plan, schedule, and execute audits of suppliers and/or contractors to ensure compliance with global regulations such as GMP, GLP, GDP, ISO, APIC, and ICH Q7. Accompany customer audits of Actylis suppliers and ensure a smooth and successful audit process. Review customer audit agendas to ensure the scope aligns with the supplier's QMS and product compliance level. Perform risk-based audits with a focus on critical areas including product quality, data integrity, and operational compliance. Plan, schedule, and execute internal audits of Actylis distribution and/or manufacturing sites with respect to corporate policies. Regulatory Compliance: Ensure compliance with international regulatory standards including FDA, EMA, WHO, ICH, ISO, and other relevant bodies. Stay updated on regulatory changes and industry best practices to maintain continuous compliance. Prepare detailed audit reports and CAPAs to mitigate risks and address non-conformities. Stakeholder Collaboration: Collaborate with cross-functional teams including Quality Assurance, Regulatory Affairs, and Supply Chain to integrate audit outcomes into improvement strategies. Work with external partners such as CMOs and third-party vendors to ensure compliance. Provide recommendations for process improvements and support remediation activities. Risk Assessment & Management: Conduct risk assessments to identify high-risk areas in global operations. Contribute to the development of annual audit plans, prioritizing audits based on risks and regulatory requirements. Documentation & Reporting: Document and communicate audit findings clearly to senior management. Follow up on implementation of corrective and preventive actions. Maintain accurate and thorough records of all audits, including any compliance violations or quality concerns. Experience Requirement: 6-10 years of experience in auditing within the pharmaceutical industry, with a strong focus on GMP compliance, regulatory affairs, or quality assurance. Solid understanding of global regulatory requirements including FDA, EMA, ICH, WHO, ISO 9001:2015, and ISO/FSSC 22000. Willingness to travel up to 60%, primarily within the APAC region, especially India. Experience in a manufacturing environment is highly desirable. Education: Bachelor, M Pharma.