Job 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
* QA activities follow legislation, authority and customer expectations
* Informs the Group Manager QA Qualification about relevant developments and trends
* Actively supports the formulation and further development of qualification strategies and continues to train accordingly
* Supports internal audits in accordance with the internal audit plan, at customer audits and official inspections as QA representative (SME)
Key Requirements:
* 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)
* Max. 40% home office possible
Please note, only those with the right to work in Switzerland can apply!
Quality Engineering Specialist • Schweizer-Reneke
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