Overview
Work history
Education
Skills
Languages
Timeline
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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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Judith Sniatecki