Quality Assurance Specialist: GMP & CAPA Expert

Alfasigma; Alanno; In loco; EUR 42.000 - 59.000; Tempo pieno

Descrizione del lavoro

Alfasigma is seeking a Senior Associate Quality Assurance to support GMP-compliant Quality System activities and records. You will manage supplier quality agreements, CAPAs, and change controls while ensuring compliance and cross-functional collaboration across manufacturing, regulatory, and technical operations.

The role emphasizes continuous improvement, documentation rigor, and effective training within the Quality Management System to meet regulatory expectations.

Competenze

• Proven experience in Quality Assurance within GMP-regulated industries.
• Strong understanding of GMP regulations related to Quality Systems.
• Experience managing Quality Agreements, CAPAs, Change Controls, and Quality Documentation/Records.
• Fluency in written and spoken English.
• Proficiency with TrackWise, SAP, Veeva, and other eQMS tools.
• Strong analytical and problem-solving skills; results-oriented and capable of meeting deadlines.

Mansioni

• Manage and maintain Quality Agreements with suppliers, contract manufacturers, and partners.
• Coordinate CAPA processes with timely implementation, monitoring, and effectiveness verification.
• Support Change Control management including impact assessments and closures.
• Ensure GMP compliance and maintain quality documentation/records.
• Monitor training within the Quality Management System and support audits/inspections.
• Collaborate with Manufacturing, Regulatory Affairs, and other functions to drive improvements.

Conoscenze

Quality Assurance

GMP regulations

Fluency in English

Analytical skills

Problem solving

Communication skills

Teamwork

Cross-functional collaboration

Independence

Quality mindset

Formazione

Bachelor's or Master's in Chemistry/Pharmaceutical Chemistry or related field

Strumenti

TrackWise

SAP

Veeva

eQMS

Descrizione del lavoro

Alfasigma is seeking a Senior Associate Quality Assurance to support GMP-compliant Quality System activities and records. You will manage supplier quality agreements, CAPAs, and change controls while ensuring compliance and cross-functional collaboration across manufacturing, regulatory, and technical operations.

The role emphasizes continuous improvement, documentation rigor, and effective training within the Quality Management System to meet regulatory expectations.