Senior GMP Auditor – QA for Sterile Biotech

Chiesi Group; Parma; Hybrid; EUR 52,000 - 65,000; Full time

Benefits offered by this job

Pension plan

Private medical insurance

Wellbeing programme

Flexible benefits programme

Relocation support

Job summary

Chiesi Group in Parma, Italy, seeks a QA Auditor to execute second- and first-party GMP audits of suppliers and service providers. The role focuses on sterile, biological and biotech products, with exposure to Quality Agreements and regulatory inspections.

We value a scientific degree and at least three years of auditing experience in pharmaceutical development or manufacturing, with strong GMP knowledge and English fluency. Hybrid working and competitive benefits are offered.

Qualifications

• Scientific degree in a related field.
• At least three years of auditor experience in pharmaceutical companies.
• Experience in Quality Assurance, supplier qualification or audit activities.

Responsibilities

• Plan and execute second party audits of GMP suppliers and service providers (CMOs, contract laboratories).
• Execute first party audits.
• Monitor follow-up of audit non-conformities and verify corrective/preventive actions.
• Coordinate external consultants supporting Auditing & Supplier Qualification.
• Define and finalize Quality Agreements with GMP suppliers and service providers.
• Support hosting GMP inspections.
• Collect and review data for Management Review and KPIs/metrics.
• Finalize, review and standardize SOPs for auditing and qualification processes.
• Organize and support training on GMP requirements and procedures.
• Act as QA reference for audit and qualification activities involving sterile, biological and biotech products.
• Interact with cross-functional teams on qualification of providers.

Skills

Leadership

Organisational skills

Stress management

Independent judgement

Team working

Networking

Decision making

Listening skills

Efficiency orientation

Fluent English

Microsoft Office (Word, Excel, Outlook

Education

Scientific degree (Pharmacy, Chemistry, Biology, Biotechnology, Pharmaceutical Sciences)

Tools

EDMS

QMS IT systems

Job description

Chiesi Group in Parma, Italy, seeks a QA Auditor to execute second- and first-party GMP audits of suppliers and service providers. The role focuses on sterile, biological and biotech products, with exposure to Quality Agreements and regulatory inspections.

We value a scientific degree and at least three years of auditing experience in pharmaceutical development or manufacturing, with strong GMP knowledge and English fluency. Hybrid working and competitive benefits are offered.