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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