Lead Auditor- Healthcare

Eurofins Assurance India Pvt Ltd is seeking a Lead Auditor specializing in the healthcare sector. This role involves conducting supplier audits in accordance with relevant regulations, Eurofins Sisthema procedures, and specific customer requirements. The successful candidate will be part of a global network dedicated to mitigating risks in supply chains across various industries, including healthcare.

Key responsibilities include managing pre-audit documentation, preparing audit agendas, and collaborating on travel arrangements. During audits, the Lead Auditor will assess supplier compliance and, post-audit, draft comprehensive reports, address client feedback, and evaluate Corrective and Preventive Action (CAPA) plans. The role also entails cross-functional collaboration with customers, suppliers, quality assurance, finance, and audit planning teams to ensure seamless audit execution and reporting.

Candidates must possess a scientific degree, preferably in Pharmacy, Chemistry and Pharmaceutical Technology, or Chemistry. A minimum of 10 years of experience in pharmaceuticals, medical devices, or cosmetics—covering areas such as Quality Assurance, Regulatory Affairs, Quality Control, or Consulting—is required. Additionally, applicants should have conducted at least 10 supplier or internal audits. Proficiency in EU GMP parts I & II, ISO standards (9001, 13485, 15378, 22716), CFR21 parts 210 and 211, EU GDP, IPEC guidelines, and Microsoft Office is essential. Strong technical audit report writing skills are mandatory.

Eurofins offers a dynamic work environment with opportunities for professional growth. Employees have access to advanced tools and software, including Microsoft Office, LIMS, SAP, and CDS systems. The company values autonomy, analytical capacity, customer and result orientation, confidentiality, and adherence to planned timelines, fostering a culture of excellence and continuous improvement.