Quality Engineering Specialist

Your responsibilities:

• Holds all quality related responsibilities for daily qualification activities on technical facilities, equipment and systems
• Supports the development, reviews and releases 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.
• 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

Your background:

• Experience in QA Qualification in biotechnology or pharmaceutical environment
• 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.