Job Title: GMP (Solid Oral Dosage) Production Specialist (m/f/d)
6 months, Full time, remote, B2B
Responsibilities
* Manage and technically process deviations, including root cause analysis, and define/track CAPAs
* Provide project-based support for CAPA and complaint management
* Create, review, and optimize SOPs and GMP documentation
* Conduct risk assessments (e.g., FMEA) and provide technical action recommendations
* Develop, prepare, and deliver GMP training as an external training service
* Perform technical reviews of manufacturing and testing documentation
* Advise department management on defined GMP and process optimization projects
Requirements
* Degree in a scientific discipline or comparable qualification
* ≥5 years’ experience in a GMP-regulated environment
* ≥3 years’ experience in solid dosage manufacturing
* Strong knowledge of deviation/CAPA management and EU-GMP regulations
* Structured, independent, and solution-oriented working style