Burcu Passiz
Freelancer
Erfahrungen
Okt. 2023 - Bis heute
1 Jahr 7 MonatenFreelancer
Burcu Passiz Consulting
Mai 2023 - Okt. 2023
6 Monaten Frankfurt am Main, Deutschland
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
Mai 2023 - Okt. 2023
6 Monaten Deutschland
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
Juli 2022 - Apr. 2023
10 Monaten Frankfurt, Deutschland
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 - Juli 2022
7 Monaten Frankfurt, Deutschland
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 - Dez. 2021
1 Jahr 11 Monaten Frankfurt, Deutschland
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 Jahren 1 Monate Frankfurt, Deutschland
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
Juni 2016 - Feb. 2017
9 Monaten Marburg, Deutschland
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
März 2015 - März 2016
1 Jahr 1 Monate Lorsch, Deutschland
GMP Trainee
Prisman GmbH
Optimization of processes for manufacturing department under GMP regulations
Sprachen
Deutsch
Muttersprache
Englisch
Verhandlungssicher
Türkisch
Verhandlungssicher
Ausbildung
Sept. 2011 - Dez. 2015
Hochschule, Koblenz
Bachelor of Science · Medizintechnik (Medical Devices) · Koblenz, Deutschland
Sept. 2010 - Juli 2011
Eberhard Gothein Schule, Mannheim
Higher School Certificate · Mannheim, Deutschland
Zertifikate & Bescheinigungen
GMP AUDITOR
PHARMAUDIT
Connected Manager
Harvard Business Publishing
Computer System Validation
VOREST AG
Quality Representative - TÜV Certified
GMP Auditor
Pharmaudit
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