Quality SGIE Specialist
• Holds all quality related responsibilities for daily qualification activities on technical facilities, equipment and systems
• Supports the development, reviews and releases qualification documents.
• Approves applicable qualification documents
• Assesses and approves change requests with regard to their relevance to the qualified state condition and ensures this supports and approves quality risk analysis (e.g. GMP-FMEA)
• Ensures that deviations are appropriately investigated and addressed in deviation reports processed in deviation reports
• QA activities follow legislation, authority and customer expectations.
• Informs the Group Manager QA Qualification about relevant developments and trend
• Actively supports the formulation and further development of qualification strategies and continues to training accordingly
• Supports internal audits in accordance with the internal audit plan, at customer audits and official inspections as QA representative (SME)
• Experience in biotechnology or pharmaceutical environment
• Experience as QA Qualification
• Knowledge on FAT/SAT/IQ/OQ/PQ
• You are proactive, with good communication skills and are able to work in a multidisciplinary team towards a common goal.
• You are fluent in English (spoken and written)
• Experience in risk analysis
• German speaking
• Knowledge of SAP, DMS and TrackWise
• Independent/pro active