Eurofins Assurance India Pvt Ltd is a leadingcertification bodyproviding Audit & Certification , Inspections , and other services covering the broad spectrum of sustainable supply chain.
Eurofins will help customers tomitigate risksin theirsupply chainand ensure benchmarking performance with operations, processes, systems, people, or capabilities.
Whether you are in the 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.
We haveaccreditationsfor a number of different industry standards/memberships to ensure we service the entire supply chain.
Job Description PURPOSE AND RESPONSIBILITIES OF THE POSITION
Carry out audits at suppliers in accordance with the reference regulations, Eurofins Sisthema procedures, and specific customer requests. Draft audit reports within agreed timelines.
DESCRIPTION OF THE ACTIVITIES
Macro Areas of Activity
Pre-audit
Management of pre-audit documents
Preparation of the audit agenda
Audit
Conducting the audit
Post-audit
Drafting of audit reports and audit comments. Drafting amended documents following customer request
Evaluation of the CAPA plan
CROSS-FUNCTIONAL (INTERNAL AND EXTERNAL) RELATIONS
Roles and Areas with which links are held
Customer
Preparation of the audit agenda, drafting of the audit report and audit comments, making any necessary corrections, and evaluation of the CAPA plan.
Supplier
Preparation of the audit agenda, conduct of the audit
QA
Reporting non-compliances
Finance
Expenses reporting
Preparation of the agenda
Collaboration for audit planning and travel preparation
Audit Customers Manager
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
Qualifications Scientific degree (preferably Pharmacy, Chemistry, and Pharmaceutical Technology)
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 and Analytical capacity
Customer and result orientation
Confidentiality
Compliance with planned timelines
Additional Information Use of equipment, utilities, software: Microsoft Office, LIMS, SAP, CDS system.
Certifications: Quality Management System, Computer System Validation, Six Sigma, ISO#J-18808-Ljbffr