About this role
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 documentsPreparation of the audit agendaCollaboration in travel preparationAudit
Conducting the auditPost-audit
Drafting of audit reports and audit comments. Drafting amended documents following customer requestEvaluation of the CAPA plan
CROSS-FUNCTIONAL (INTERNAL AND ETERNAL) RELATIONS
Roles and Areas with which links are held
Customer
Preparation of the audit agenda, drafting of the audit report and audit comments, make any necessary corrections and evaluation of the CAPA plan.Supplier
Preparation of the audit agenda, conduct of the auditQA
Reporting non-compliancesFinance
Expenses reportingAudit Sales & Planning Specialist
Preparation of the agendaCollaboration for audit planning and travel preparationAudit Sales & Planning Assistant
Preparation of the agendaCollaboration for audit planning and travel preparationAudit Customers Manager
Collaboration in the technical review of the audit reports. Collaboration following customer requestsAudit Operations & Audit Sales Man
Collaboration in the auditor qualification process. Reporting issues emerged during the audit Educational qualification-
Scientific degree (preferably Pharmacy, Chemistry and Pharmaceutical Technology, Chemistry)Technical Audit Report Writing skills are mandatory.Previous experience-
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 auditsKnowledge 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
Transversal skills-
Attention to order and Quality Self-controlAutonomy Analytical capacityCustomer and result orientation ConfidentialityCompliance with planned timelines Use of equipment, utilities, software-Microsoft Office, LIMS, SAP, CDS system.
Certifications-Quality Management System, Computer System Validation, Six Sigma, ISO