Required skills
- Root Cause Analysis
- Quality Management
- CAPA Management
- GMP
- Process Optimization
- Regulatory Compliance
- Pharmaceutical Industry
- Chemical Industry
- Biotechnology
- Food Industry
- Microsoft Office
Languages: German
Job description
The role involves investigating deviations, performing root cause analyses, and managing corrective and preventive actions within a quality management system. The scientist will collaborate with various departments to optimize processes and ensure compliance.
Responsibilities
Profile
- Investigation of deviations, performance of root cause analyses, and writing of well-founded deviation reports
- Participation in initial assessments as well as opening and coordination of deviations in the quality management system
- Creation, processing, and follow-up of Corrective and Preventive Actions (CAPAs) until successful completion
- Close collaboration with Production, Quality Assurance, Engineering, Supply Chain, and other interdisciplinary specialist areas
- Analysis of process data and derivation of suitable optimization measures for continuous improvement of processes and compliance
- Ensuring compliance with internal quality standards and regulatory requirements
- Completed scientific degree (e.g., Pharmacy, Chemistry, Biology) (University or FH) or several years of experience in the specialist area (sterile filling)
- Professional experience in the chemical, pharmaceutical, biotech, or food industry as well as in a GMP-regulated environment
- Experience in processing deviations, root cause analyses, and creating investigation reports
- Strong analytical and conceptual skills as well as structured problem-solving competence
- Good knowledge of quality management systems as well as CAPA, Change Control, and Risk Management processes are an advantage
- Independent, meticulous, and quality-conscious way of working
- Quick comprehension and enjoyment of familiarizing oneself with new subject areas
- Team-oriented personality with high initiative and strong communication skills
- Confident use of common Microsoft Office applications; experience with electronic quality management systems (e.g., TrackWise, Veeva) is an advantage
Project details
- Start: 01/27
- Location: Bern, CH, CH
- Languages: German
Source notes
- Varied work in a renowned company
- Support throughout the entire application process
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