Burcu Passiz
Freelancer
Experience
Oct 2023 - Present
1 year 7 monthsFreelancer
Burcu Passiz Consulting
May 2023 - Oct 2023
6 months Frankfurt am Main, Germany
Freelancer: Data Integrity Consultant
Burcu Passiz Consulting
- Creation of Audit Trail Concepts and Access Management Concepts
- Review of Audit Trail Concepts and Access Management Concepts
- Stakeholder management
- Ensuring and implementation of regulatory requirements regarding Data Integrity
May 2023 - Oct 2023
6 months Germany
Freelancer: Validation Manager
Burcu Passiz Consulting
- Planning, implementation and completion of process validation including creation of reports
- Creation of critical risk assessments
- Creation of validation/qualification protocols and reports
Jul 2022 - Apr 2023
10 months Frankfurt, Germany
Consultant: Validation Manager
Capgemini Engineering
- Planning, implementation and completion of process validation including creation of reports
- Creation of risk assessments
- Introduction of single use systems
Jan 2021 - Jul 2022
7 months Frankfurt, Germany
Consultant: Project Management
Capgemini Engineering
- Introduction of a new document management system: Veeva Quality Docs (VQD)
- Creation of a project plan
- Monitoring and coordination of project milestones
- Training and consulting
- Participation in global project meetings
- Stakeholder management
Feb 2020 - Dec 2021
1 year 11 months Frankfurt, Germany
Consultant: Change Manager
Altran GmbH
- Coordination, implementation and completion of change requests for the reduction of animal testing (3R: Replacement, Reduction and Refinement)
- Implementation of CSV including report creation
- Project coordination
- Exchange with global project teams
- Reporting KPI
Feb 2017 - Feb 2020
3 years 1 month Frankfurt, Germany
Consultant: Process Specialist
Altran GmbH
Certified Change Manager and Mentor
- Coordination, planning and execution of change requests for the manufacturing of vaccines
- Preparation of risk assessments
- Creation of deviation reports
- Creation of CAPAs
- Inspection readiness
Jun 2016 - Feb 2017
9 months Marburg, Germany
IT Consultant
Altran GmbH
- Implementation of data and system migration to the new IT infrastructure
- GMP-compliant documentation of migration activities of GxP laboratory systems
- Review of GMP-compliant documentation
Mar 2015 - Mar 2016
1 year 1 month Lorsch, Germany
GMP Trainee
Prisman GmbH
Optimization of processes for manufacturing department under GMP regulations
Languages
German
Native
English
Advanced
Turkish
Advanced
Education
Sep 2011 - Dec 2015
Hochschule, Koblenz
Bachelor of Science · Medizintechnik (Medical Devices) · Koblenz, Germany
Sep 2010 - Jul 2011
Eberhard Gothein Schule, Mannheim
Higher School Certificate · Mannheim, Germany
Certifications & licenses
GMP AUDITOR
PHARMAUDIT
Connected Manager
Harvard Business Publishing
Computer System Validation
VOREST AG
Quality Representative - TÜV Certified
GMP Auditor
Pharmaudit
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