Senior Quality Assurance Auditor (GxP)

Ergomed; Lisboa; In loco; EUR 55.000 - 85.000; Tempo pieno

Descrizione del lavoro

Ergomed Group brings together Ergomed CRO, PrimeVigilance, Prudentia, and ADAMAS Consulting to support biopharmaceutical companies in developing, delivering and safeguarding therapies worldwide.

The Senior Auditor, Quality Assurance role manages internal and contracted audits, contributes to audit strategy, and leads complex audits with GxP expertise, while providing QA consultancy across the organization.

Competenze

• Bachelor's degree in a scientific discipline is required.
• Master's degree preferred or equivalent industry experience.
• GVP & GCP knowledge with auditing experience in an Audit Lead role.
• Strong analytical, written and oral communication skills.
• Fluent in English; additional languages a plus but not required.

Mansioni

• Lead and conduct audits for the Company and Clients according to the Audit Program.
• Provide QA consultancy activities within GxP, including SOP development and CAPA reviews.
• Main QA contact for designated Clients and oversight of audits.
• Support audits and inspections by regulatory authorities.
• Contribute to strategic internal audit program and knowledge sharing.

Conoscenze

Pharmacovigilance

Analytical skills

English

Formazione

Bachelor’s degree in scientific discipline

Master’s degree preferred

Descrizione del lavoro

Ergomed Group brings together Ergomed CRO, PrimeVigilance, Prudentia, and ADAMAS Consulting to support biopharmaceutical companies in developing, delivering and safeguarding therapies worldwide.

The Senior Auditor, Quality Assurance role manages internal and contracted audits, contributes to audit strategy, and leads complex audits with GxP expertise, while providing QA consultancy across the organization.