Senior GCP QA Auditor — Global R&D, Hybrid Parma

Chiesi Farmaceutici S.p.A.; Parma; Hybrid; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Pension

Private medical insurance

Job summary

Chiesi Farmaceutici S.p.A. in Parma seeks an experienced GCP QA professional to verify compliance, manage CAPAs, and support quality metrics across Global R&D. The role includes audits at clinical studies and with vendors, and oversight of QA documents and training programs.

Responsibilities cover CAPA plans, KPI reporting, TrackWise workflows, and collaboration with Clinical, Pharmacovigilance and Procurement teams. A strong background in GCP and audits is essential for success.

Qualifications

• At least 3 years’ experience in Pharmaceutical/Consultancy/CRO QA in R&D with GCP knowledge.
• At least 2 years of experience as a GCP auditor.
• Knowledge of GCP requirements and quality systems.
• Understanding of the pharmaceutical development process across all trial phases.
• Experience with auditing techniques and training methods.
• Fluent English, written and spoken.

Responsibilities

• Verify and ensure GCP compliance; manage GCP CAPAs and KPIs.
• Prepare quality metrics; support Global R&D quality activities.
• Manage TrackWise and QA documentation; handle supplier/audit workflows.
• Support external consultants for auditing, due diligence and supplier qualification.
• Finalize Quality Documents and SOPs for audits and qualification.
• Write/review SOPs related to audit/qualification of clinical service providers.
• Ensure training on GCP activities and maintain traceability.
• Execute GCP first/second party audits at studies and vendors.
• Finalize and manage GCP audit reports; liaise with Clinical, Pharmacovigilance and Procurement.

Skills

Fluent English

Planning skills

Organizational skills

Strategic thinking

Quality orientation

Tools

TrackWise

Job description

Chiesi Farmaceutici S.p.A. in Parma seeks an experienced GCP QA professional to verify compliance, manage CAPAs, and support quality metrics across Global R&D. The role includes audits at clinical studies and with vendors, and oversight of QA documents and training programs.

Responsibilities cover CAPA plans, KPI reporting, TrackWise workflows, and collaboration with Clinical, Pharmacovigilance and Procurement teams. A strong background in GCP and audits is essential for success.