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Contractor Quality SGIE Specialist (m/w/d) (EN)
[13266]
QA Qualification, FAT, SAT, IQ, OQ, PQ
Job title: Quality SGIE Specialist Industry: Biotech Skills: QA Qualification,FAT,SAT,IQ,OQ,PQ Start of project: 01.07.2023 Duration of the project : 4 months Project volume: 100% Location: 3930 Visp, Schweiz Tasks: ·Holds all quality related responsibilities for daily qualification activities on technical facilities, equipment and systems. ·Supports the development, reviews and releases qualification documents according to the validation master plan. ·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. ·Confirms the qualified status of technical equipment and systems during their life cycle by means of regular inspections of their qualification. ·QA activities follow legislation, authority and customer expectations. ·Informs the Group Manager QA Qualification / Validation 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). Qualifications: ·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). ·Beneficial skills: ·Experience in risk analysis ·German speaking ·Knowledge of SAP, DMS and TrackWise ·Independent/pro active