GCP Quality & Compliance Lead

Biopharma Careers; Parma; Ibrido; EUR 41.000 - 51.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Wellbeing programme

Flexible benefits

Relocation support

Descrizione del lavoro

Chiesi in Parma is seeking a QA professional to verify GCP compliance and manage CAPAs from audits within Global R&D. The role focuses on quality metrics, document management, and audit support in a hybrid headquarters environment.

The candidate should have at least 3 years in QA for pharma/consultancy/CRO, strong GCP knowledge, and an English proficiency. A scientific degree is required and relocation support may be offered.

Competenze

• At least 3 years’ experience in Pharmaceutical/Consultancy/CRO in the Research & Development environment Quality Assurance.
• Knowledge of GCP requirements and quality system.
• Knowledge of the pharmaceutical development process supporting clinical trials.
• Knowledge of training technique.
• Scientific degree and good knowledge of English.

Mansioni

• Manage CAPA plans from GCP audits and ensure follow-up.
• Collect quality metrics and KPIs to support Global R&D.
• Handle TrackWise, supplier and audit workflows.
• Support external consultants in Auditing & Supplier Qualification Unit.
• Finalize Quality Documents for the unit.
• Write/review SOPs relating to audit and qualification of clinical service providers.
• Ensure training on relevant activities and procedures.
• Ensure good documentation and traceability.
• Execute GCP first and second party audits.

Conoscenze

GCP knowledge

Quality Assurance

Auditing

English proficiency

Formazione

Scientific degree

Strumenti

TrackWise

Descrizione del lavoro

Chiesi in Parma is seeking a QA professional to verify GCP compliance and manage CAPAs from audits within Global R&D. The role focuses on quality metrics, document management, and audit support in a hybrid headquarters environment.

The candidate should have at least 3 years in QA for pharma/consultancy/CRO, strong GCP knowledge, and an English proficiency. A scientific degree is required and relocation support may be offered.