Lead Auditor- Healthcare

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
• Collaboration in travel preparation

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 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 audit

QA

• Reporting non-compliances

Finance

• Expenses reporting

Audit Sales & Planning Specialist

• Preparation of the agenda
• Collaboration for audit planning and travel preparation

Audit Sales & Planning Assistant

• 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

Audit Operations & Audit Sales Man

• Collaboration in the auditor qualification process. Reporting issues emerged during the audit

Qualifications

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 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

Transversal skills-

• Attention to order and Quality Self-control
• Autonomy 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