We are a growing pharmaceutical company specialized in the manufacturing of sterile injectable products with terminal sterilization. We operate both as a manufacturer and as a Contract Manufacturing Organization (CMO), supporting international clients in the development and production of high-quality injectable medicines.
We are looking for an experienced and motivated Serialization Lead.
Key Responsibilities
Own and execute the serialization roadmap, supporting change management activities
Ensure compliance with EU FMD, US DSCSA, Chinese serialization requirements, and other applicable global regulations
Manage serialization system lifecycle activities including configuration, master data setup, CSV/CPV, and change control
Act as escalation point for serialization and aggregation issues at the site and external partners, ensuring system stability (Level 1 – 4 architecture)
Support regulatory inspections, customer audits, and internal compliance assessments
Develop and maintain SOPs, validation documentation, and training materials in line with GMP requirements
Monitor serialization KPIs and drive continuous improvement initiatives
Profile
5+ years of experience in pharmaceutical manufacturing and/or packaging (ideally sterile injectables)
Solid experience in pharmaceutical serialization within GMP environments
Strong knowledge of EU FMD, US DSCSA, and familiarity with Chinese serialization requirements
Experience in Computer System Validation (CSV), change control, and validation activities
Understanding of labelling requirements, barcode standards, and serialization systems
Strong project management and problem-solving skills in multi-stakeholder environments
Ability to manage multiple priorities in a fast-paced global CMO context
Fluent English (written and spoken)