Eurofins Assurance India Pvt Ltd is a leading certification body providing Audit & Certification, Inspections, and other services covering the broad spectrum of sustainable supply chain.
Eurofins will help the customers to mitigate risks in their supply chain and to ensure the benchmarking performance with operations, processes, systems, people or capabilities.
Whether you are in Food, Cosmetics, Consumer products or Health care sector, our global auditor and technical expert network will help to mitigate/eliminate your risks against supply chain and distribution flows: Regulatory and Industrial standards.
Carry out audits at suppliers in accordance with the reference regulations, Eurofins Sisthema procedures and specific customer requests. Draft audit reports within agreed timelines.
Macro Areas of Activity
Management of pre-audit documents
Preparation of the audit agenda
Collaboration in travel preparation
Conducting the audit
Drafting of audit reports and audit comments. Drafting amended documents following customer request
Evaluation of the CAPA plan
Roles and Areas with which links are held
Preparation of the audit agenda, drafting of the audit report and audit comments, make any necessary corrections and evaluation of the CAPA plan.
Preparation of the audit agenda, conduct of the audit
Reporting non-compliances
Expenses reporting
Preparation of the agenda
Collaboration for audit planning and travel preparation
Preparation of the agenda
Collaboration for audit planning and travel preparation
Collaboration in the technical review of the audit reports. Collaboration following customer requests
Collaboration in the auditor qualification process. Reporting issues emerged during the audit
Scientific degree (preferably Pharmacy, Chemistry and Pharmaceutical Technology, Chemistry)
Technical Audit Report Writing skills are mandatory.
Experience of minimum 10 plus years in the field of pharmaceuticals, medical devices and / or cosmetics (QA, Regulatory Affairs, QC, Consulting)
Conducting at least 10 supplier audits and/or internal audits
Knowledge of- EU GMP part I & II, ISO 9001, ISO 13485, ISO 15378, ISO 22716,CFR21 part 210,211, EU GDP, IPEC guidelines, English language level C, Microsoft Office
Specific technical practical skills (know-how) - Conducting Audits of Quality Management Systems
Attention to order and Quality Self-control
Autonomy Analytical capacity
Customer and result orientation Confidentiality
Compliance with planned timelines
Use of equipment, utilities, software-Microsoft Office, LIMS, SAP, CDS system.
Certifications-Quality Management System, Computer System Validation, Six Sigma, ISO
Originally posted by Eurofins. View original posting
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