QA Operations Specialist (m/f/d)

Responsibilities:

• Ensure shop floor QA oversight (regular presence in the cleanroom)
• Assess, review, and approve GMP documents and quality records e.g. SOPs, risk assessments, deviations, investigation, CAPAs, change controls, rotocols, executed MBRs
• Act as QA representative during the conduction of internal / customer / regulatory inspections and  audits
• Provide GMP-related training to Operations personnel
• Support continuous improvement programs to establish an effective Quality Management System for DPS

Requirements:

• Master of Science in biotechnology or a related field
• Significant work experience (3-5 years) in the GMP-regulated environment, about aseptic manufacturing activities and preferably within a Quality Unit
• Experience working with stakeholders from different departments and management levels
• Fluent in English (written and spoken), German language is an advantage