QA Associate - Temporary Maternity Leave Coverage

Alfasigma; Bologna; A distancia; EUR 35.000 - 52.000; Jornada completa

Descripción de la vacante

Alfasigma is seeking an Associate, Quality Assurance to support GMP-compliant quality system activities at the Alanno site, focusing on CAPA closures and management of Quality Agreements with customers involved in third-party manufacturing. The role emphasizes collaboration with global affiliates and cross-functional teams.

The ideal candidate holds a science degree and demonstrates fluent English, strong GMP knowledge, and experience with TrackWise, SAP, and Veeva.

Formación

• You have a solid understanding of GMP regulations, particularly in relation to Quality Systems, together with proven experience in Quality Assurance.
• You are fluent in written and spoken English.
• You are proficient in IT tools and quality systems, such as TrackWise, SAP, and Veeva.
• You bring strong analytical and problem-solving skills, combined with a results-oriented mindset.
• You are able to work independently and effectively manage priorities and deadlines.
• You are detail-oriented, organized, and skilled in document management.
• You have excellent communication and teamwork skills, with the ability to collaborate across departments and contribute to group objectives.

Responsabilidades

• Manage Quality Agreements with customers for third-party manufacturing activities, ensuring consistency, compliance, and alignment with agreed expectations and global affiliate requirements.
• Support the management and timely closure of Corrective and Preventive Actions (CAPAs).
• Coordinate and monitor change control activities within the Alanno environment.
• Ensure that Quality System activities are performed in accordance with GMP requirements, internal procedures, and business priorities.
• Maintain accurate, complete, and well-organized quality documentation.
• Collaborate effectively with cross-functional departments, customers, and global affiliates to support shared quality objectives.
• Monitor priorities and deadlines, proactively identifying issues and supporting effective solutions.

Conocimientos

Analytical and problem-solving

Communication skills

Teamwork

Educación

A degree in a scientific discipline such as Chemistry, Pharmaceutical Chemistry and Technology, Chemical Engineering, Biology, or Pharmaceutical Biotechnology

Herramientas

TrackWise

SAP

Veeva

Descripción del empleo

Alfasigma is seeking an Associate, Quality Assurance to support GMP-compliant quality system activities at the Alanno site, focusing on CAPA closures and management of Quality Agreements with customers involved in third-party manufacturing. The role emphasizes collaboration with global affiliates and cross-functional teams.

The ideal candidate holds a science degree and demonstrates fluent English, strong GMP knowledge, and experience with TrackWise, SAP, and Veeva.