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.
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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 xivgfpx 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)