Senior QA Auditor (GMP) – Sterile & Biotech Focus

Chiesi Farmaceutici S.p.A.; Parma; Híbrido; EUR 52 000 - 65 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Pension

Private medical insurance

Wellbeing programme

Flexible benefits

Relocation support

Resumo da oferta

Chiesi Farmaceutici S.p.A. in Parma, Italy, is seeking an experienced QA Auditor to support first and second party audits, supplier qualification, and Quality Agreements within a GMP-driven global R&D environment.

Based in Parma with a flexible hybrid arrangement, you will collaborate across CMC, Regulatory Affairs, Clinical Supply and Procurement to ensure sterility and biotech product standards are met, and you will mentor external consultants when needed.

Qualificações

• Minimum three years of auditor experience in pharmaceutical companies.
• Experience in QA, supplier qualification or audit activities in pharma development/manufacturing.
• Knowledge of GMP requirements.
• Knowledge of auditing techniques.
• Knowledge of sterility assurance for sterile/biotech products.
• Fluent English, written and spoken.
• Proficiency with Microsoft Office (Word/Excel/Outlook/PowerPoint).
• Leadership and teamwork abilities.

Responsabilidades

• Plan and execute second party audits of GMP suppliers and service providers.
• Execute first party audits.
• Monitor follow-up of audit non-conformities and CAPA closures.
• Coordinate external consultants supporting Auditing & Supplier Qualification.
• Define, review and finalize Quality Agreements with GMP suppliers.
• Support hosting of GMP inspections.
• Collect and review data for Management Review and KPIs.
• Standardize SOPs related to auditing and qualification processes.
• Organise and support training on GMP requirements.
• Act as QA reference for audits involving sterile, biological and biotech products.
• Interact with cross-functional teams (CMC, Regulatory, Clinical Supply, Procurement).

Conhecimentos

Fluent English

GMP knowledge

Auditing techniques

Sterility assurance

Leadership

Organisational skills

Independent judgement

Teamwork

Networking

Decision making

Listening skills

Efficiency orientation

Microsoft Office

PowerPoint

Formação académica

Pharmacy, Chemistry, Biology, Biotechnology, Pharmaceutical Sciences or related

Ferramentas

EDMS

QMS IT systems

Descrição da oferta de emprego

Chiesi Farmaceutici S.p.A. in Parma, Italy, is seeking an experienced QA Auditor to support first and second party audits, supplier qualification, and Quality Agreements within a GMP-driven global R&D environment.

Based in Parma with a flexible hybrid arrangement, you will collaborate across CMC, Regulatory Affairs, Clinical Supply and Procurement to ensure sterility and biotech product standards are met, and you will mentor external consultants when needed.