GCP Specialist R&D (Auditing)

Location: Parma, Italy; based at headquarters with a flexible hybrid working arrangement

Salary: Minimum €46,000 annual salary, plus eligibility for an annual performance bonus.

Company

Chiesi is an international research-focused biopharmaceutical group headquartered in Parma, Italy, operating in more than 30 countries with over 8,000 employees.

What you will do

• Manage CAPA plans resulting from GCP audits.
• Collect and manage quality metrics and KPIs supporting Global R&D departments.
• Manage Trackwise, supplier, and audit workflows.
• Prepare and maintain quality documents, GCP audit reports, and related records.
• Write and review SOPs for auditing and qualification of clinical service providers.
• Execute first- and second-party GCP audits and support external consultants.

Requirements

• At least three years of experience in pharmaceutical, consultancy, or contract research organizations within R&D quality assurance.
• Robust knowledge of GCP supporting clinical trials, compliance requirements, and quality systems.
• Knowledge of the pharmaceutical development process supporting clinical trials.
• Knowledge of training techniques and good documentation and traceability practices.
• Scientific degree required.
• Good knowledge of English required.

Nice to have

• Knowledge of auditing techniques.
• ISO auditor certification.

Culture & Benefits

• Pension and private medical insurance.
• Wellbeing and flexible benefits programmes.
• Work-life balance initiatives and flexible working arrangements.
• Relocation support and tax assistance services for foreign colleagues.
• Access to resources and training supporting professional development.