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Contractor Quality SGIE Specialist (m/w/d)
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3930 Visp, Schweiz |
Temporary Employment
Job title: Quality SGIE Specialist
Industry: BiotechSkills: 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
Referenznummer:
Branche:
Beginn des Projekts:
Dauer:
Anstellungsart:
Kontakt
Julia Ojeda
13266
Biotech
01.08.2023
4 months
Temporary Employment
