Technician Quality Oversight Production

Responsibilities

• Perform QA oversight in cleanrooms, production, inspection, labeling, packaging, and shipping
• Review manufacturing protocols, logbooks, environmental monitoring, and sterilization data
• Monitor and control cleaning processes and product separation
• Release cleanrooms and production equipment following changes
• Initiate and support deviation investigations, CAPAs, and Change Controls
• Support regulatory and customer audits, SOP adjustments, and continuous improvement measures
• Collect data for trend analysis to implement continuous improvements
• Escalate critical issues to higher quality assurance authorities

Requirements

• Completed training as a pharmaceutical technician (Pharmakant), chemical laboratory technician, or a degree in a scientific field
• At least 2 years of experience in aseptic manufacturing preferred
• Very good knowledge of international cGMP regulations
• High communication skills and strong service/quality orientation
• Independent, careful, and solution-oriented working style
• Proficiency in MS Office, eQMS systems (e.g., Veeva, TrackWise), and basic ERP knowledge
• Very good German and English skills (written and spoken)
• Willingness to work in a rotating shift system

About the Company

Simtra is a premier contract development and manufacturing organization that has been bringing sterile, injectable medicines to market for over 65 years in collaboration with more than 60 international customers worldwide. Our primary focus is on the manufacture of cancer therapeutics.