QA Associate — GMP/CAPA & Quality Agreements (Temp)

Alfasigma; Alanno; On-site; EUR 35,000 - 42,000; Full time

Job summary

Alfasigma is seeking an Associate, Quality Assurance for a temporary maternity leave replacement at the Alanno site. You will manage Quality Agreements with customers for third-party manufacturing, support CAPA closures, and coordinate change control activities.

Ideal candidates hold a science degree, have GMP QA experience, and are fluent in English. Proficiency with TrackWise, SAP and Veeva is expected, along with strong analytical and documentation skills.

Qualifications

• Degree in Chemistry, Pharmaceutical Chemistry & Technology, Chemical Engineering, Biology, or Pharmaceutical Biotechnology.
• Solid GMP knowledge with QA experience and Quality Systems.
• Fluent written and spoken English.
• Proficient in TrackWise, SAP and Veeva.
• Strong analytical and problem-solving skills with a results-oriented mindset.
• Able to work independently and manage priorities and deadlines.
• Detail-oriented, organized and skilled in document management.
• Excellent communication and teamwork across departments.

Responsibilities

• 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 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.

Skills

GMP principles

Quality Assurance

English fluency

TrackWise

SAP

Veeva

Analytical thinking

Communication

Education

Science degree

Tools

TrackWise

SAP

Veeva

Job description

Alfasigma is seeking an Associate, Quality Assurance for a temporary maternity leave replacement at the Alanno site. You will manage Quality Agreements with customers for third-party manufacturing, support CAPA closures, and coordinate change control activities.

Ideal candidates hold a science degree, have GMP QA experience, and are fluent in English. Proficiency with TrackWise, SAP and Veeva is expected, along with strong analytical and documentation skills.