GCP Quality & Audit Specialist (CAPA & Metrics)

Biopharma Careers; Parma; Ibrido; EUR 35.000 - 43.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus scheme

Private medical insurance

Wellbeing programme

Flexible benefits programme

Relocation support

Descrizione del lavoro

Chiesi Research & Development in Parma is seeking a Quality Assurance professional to verify and ensure GCP compliance across CAPAs, audits, and QA documentation. You'll manage quality metrics and support audits within Global R&D.

Based at the Parma HQ with a flexible hybrid working arrangement, you will collaborate with external consultants and internal teams, write SOPs, and ensure traceability and regulatory compliance throughout clinical trials.

Competenze

• At least 1 year in Pharmaceutical, Consultancy or CRO QA with GCP knowledge for clinical trials.
• Knowledge of GCP requirements and quality systems.
• Experience with pharmaceutical development processes for clinical trials.
• English language proficiency.

Mansioni

• Manage GCP CAPAs and quality metrics supporting compliance.
• Prepare and review quality documents and SOPs for audit readiness.
• Execute first and second party audits and track audit findings.
• Support external consultants and qualification workflows.
• Maintain training and ensure traceability of records.

Conoscenze

GCP compliance

Quality Assurance

Audit management

SOP writing

Training

English proficiency

Formazione

Scientific degree

Strumenti

TrackWise

Audit software

Descrizione del lavoro

Chiesi Research & Development in Parma is seeking a Quality Assurance professional to verify and ensure GCP compliance across CAPAs, audits, and QA documentation. You'll manage quality metrics and support audits within Global R&D.

Based at the Parma HQ with a flexible hybrid working arrangement, you will collaborate with external consultants and internal teams, write SOPs, and ensure traceability and regulatory compliance throughout clinical trials.