Senior QA Auditor - GxP Compliance & Audit Lead

Ergomed; Lazio; On-site; EUR 60,000 - 90,000; Full time

Job summary

Ergomed Group is a leading provider of clinical research, pharmacovigilance, and quality consulting. The Senior Auditor, Quality Assurance role entails managing and conducting internal and contracted audits for the Company and Clients, guiding audit strategy and risk-based planning.

You will lead complex audits, act as main QA contact for designated clients, and contribute to Quality as a Service, including mock inspections, training and SOP development.

Qualifications

• Pharmaceutical/pharmacovigilance experience with GVP/GCP auditing.
• Strong analytical, written, and oral communication skills.
• Ability to manage multiple tasks and meet deadlines.

Responsibilities

• Lead internal and contracted audits per the Audit Program.
• Manage pre-audit activities and risk-based planning.
• Provide QA consultancy, SOP development and gap analysis.
• Act as main QA contact for designated Clients and audits.
• Support training and development of auditors.

Skills

Pharmacovigilance

GVP & GCP knowledge

Auditing

Analytical skills

Written and oral communication

Team player

English fluent

Education

Bachelor's degree in a scientific discipline

Master's degree preferred or equivalent experience

Job description

Ergomed Group is a leading provider of clinical research, pharmacovigilance, and quality consulting. The Senior Auditor, Quality Assurance role entails managing and conducting internal and contracted audits for the Company and Clients, guiding audit strategy and risk-based planning.

You will lead complex audits, act as main QA contact for designated clients, and contribute to Quality as a Service, including mock inspections, training and SOP development.