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.
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