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
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