EU Serialisation & Artwork Specialist

Shionogi Europe; Amsterdam; On-site; EUR 60,000 - 90,000; Full time

Job summary

Shionogi Europe is seeking a Serialisation and Artwork Specialist to coordinate serialisation activities and support end-to-end artwork processes across products, markets and regions. You will ensure compliant packaging, timely changes and ongoing supply continuity through close collaboration with QA, RA, Supply Chain and external partners.

The role requires a bachelor’s degree in a regulated field and at least three years of pharma experience, with strong English skills and willingness to

Qualifications

• Bachelor’s degree in a regulated field (life sciences/pharma) or equivalent experience.
• At least 3 years of relevant pharma/regulated industry experience.
• Knowledge of pharmaceutical serialisation and artwork processes including EU FMD.
• Knowledge of GxP requirements and change-control processes.
• Experience working cross-functionally in a matrix organisation; English proficiency.

Responsibilities

• Coordinate serialisation activities in line with EU FMD and local rules; manage master data and external partners.
• Support artwork changes and maintenance across the lifecycle; align drawings and packaging components with QA, RA and partners.
• Assist with artwork-related change controls, documentation and impact assessments per EMA/EU FMD requirements.
• Act as a key contact for serialisation and artwork across Shionogi Europe with internal teams, CMOs, packers and IT/providers.

Skills

Organisational skills

Attention to detail

Project management

Cross-functional collaboration

English proficiency

Education

Bachelor's degree in life sciences / pharmaceutical operations / supply chain / packaging / technical operations

Tools

Rfxcel

ERP systems

Serialisation software

Job description

Shionogi Europe is seeking a Serialisation and Artwork Specialist to coordinate serialisation activities and support end-to-end artwork processes across products, markets and regions. You will ensure compliant packaging, timely changes and ongoing supply continuity through close collaboration with QA, RA, Supply Chain and external partners.

The role requires a bachelor’s degree in a regulated field and at least three years of pharma experience, with strong English skills and willingness to