Judith Sniatecki
Roggenburg,Germany
Overview
13
13
years of professional experience
4
4
years of post-secondary education
Work history
Head of Quality Compliance
Teva Biotech GmbH
Ulm, Germany
01.2024 - Current
- Ensuring compliance with all quality-related national and international guidelines and legal requirements, as well as internal corporate quality standards
- Lead, motivate and develop employees in accordance with company's leadership principles
- Responsibility for personnel and budget planning
- Responsibility for regulatory inspections (inspection preparation, management, responses)
- Owner of supplier qualification, Quality related contracts and internal audit management including streamlining of processes to enhance efficiency
- Reporting of key performance indicators including evaluation of results and establishing measures
Hygienic Lead Production Support
Teva Biotech GmbH
Ulm, Germany
02.2021 - 12.2023
- Responsibility for hygiene concepts and gowning concept for clean rooms, enhancement of existing concepts
- Establishment of new concepts during construction, commissioning and qualification of new facility for biopharmaceuticals
- Responsibility for personnel and budget
- SME for regulatory inspections and audits (preparation, presentation, responses)
Quality Analyst
Teva Biotech GmbH
Ulm, Germany
01.2013 - 01.2021
- Business Owner of TrackWise Harmony (QMS Software)
- Quality Approver for Change Controls, Deviation Investigations and CAPAs
- Responsibility for clean room classes (concept, requirements etc.)
- Responsibility for environmental monitoring concept
- Inspection readiness and SME in regulatory inspections and audits
- Continuous evaluation and implementation of regulatory and Teva corporate requirements
Education
Master of Science - Biotechnology
University of Applied Sciences Mannheim
Mannheim, Germany 09.2011 - 07.2012
Bachelor of Engineering - Medical Engineering, Biotechnology
University of Applied Sciences Ulm
Ulm, Germany 09.2007 - 02.2011
Skills
- Regulatory compliance
- Performance metrics
- Project management
- Team coaching
- Conflict resolution
- GMP practices adherence
- Audit supervision
- Internal auditing
Languages
English
Fluent
French
Elementary
Spanish
Beginner
German
Native
Timeline
Head of Quality Compliance
Teva Biotech GmbH
01.2024 - Current
Hygienic Lead Production Support
Teva Biotech GmbH
02.2021 - 12.2023
Quality Analyst
Teva Biotech GmbH
01.2013 - 01.2021
Master of Science - Biotechnology
University of Applied Sciences Mannheim
09.2011 - 07.2012
Bachelor of Engineering - Medical Engineering, Biotechnology
University of Applied Sciences Ulm
09.2007 - 02.2011
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