Burcu P.
QA Validation/Qualification
Experience
Apr 2024 - Sep 2024
6 monthsQA Validation/Qualification
Burcu Passiz Consulting
- Review and release of validation documents, reports, and standard operating procedures (SOP).
- Review of change controls, risk analyses, FMEAs, qualification reports, periodic evaluations, and RTMs.
Aug 2023 - Present
2 years 3 monthsLampertheim, Germany
Data Integrity Consultant
Burcu Passiz Consulting
- Conduct data integrity gap assessments.
- Create documents on data integrity, audit trail concepts, and access management concepts.
- Ensure and implement regulatory requirements for data integrity.
May 2023 - Aug 2023
4 monthsValidation Manager
Burcu Passiz Consulting
- Plan, execute, and close process validations including report generation.
- Create Critical Risk Assessments (CRAs), validation protocols, and validation reports.
Jul 2022 - Apr 2023
10 monthsFrankfurt am Main, Germany
Validation Manager
Altran GmbH (Capgemini)
- Plan, execute, and close process validations including report generation.
- Create risk assessments and introduce single-use systems.
Jan 2022 - Jul 2022
7 monthsFrankfurt am Main, Germany
Project Management
Altran GmbH
- Implement a new document management system: Veeva Quality Docs (VQD).
- Create a project plan, monitor and coordinate project milestones.
- Train and advise on system use and liaise with global project teams.
Feb 2020 - Dec 2021
1 year 11 monthsFrankfurt am Main, Germany
3R Change Manager
Altran GmbH
- Coordinate, execute, and close change requests to reduce animal testing (3R: Replacement, Reduction, and Refinement).
- Perform computer system validations (CSV) including report generation.
- Manage project coordination and communicate with external project teams.
Feb 2017 - Feb 2020
3 years 1 monthFrankfurt am Main, Germany
Process Specialist
Altran GmbH
- Coordinate, plan, and execute change requests for vaccine production.
- Create risk assessments and qualification documents.
- Lead team change meetings, prepare and present at inspections.
- Develop KPIs and CAPAs, initiate and document deviations.
- Lead project teams.
Jun 2016 - Feb 2017
9 monthsFrankfurt am Main, Germany
IT Consultant
Altran GmbH
- Conduct data and system migration to new IT infrastructure.
- Document the migration of GxP lab systems in line with GMP requirements.
- Review GMP-compliant documentation.
Mar 2015 - Mar 2016
1 year 1 monthLorsch, Germany
GMP Trainee
Prisman GmbH
- Optimize process workflows for disinfectant production.
Languages
German
NativeEnglish
AdvancedTurkish
AdvancedEducation
Oct 2011 - Dec 2014
Koblenz University of Applied Sciences
Bachelor of Science · Biomedical Engineering · Koblenz, Germany
Sep 2010 - Jul 2011
Eberhard Gothein School, Business High School
Advanced Technical College Entrance Qualification · Mannheim, Germany
Certifications & licenses
Pharmaaudit GMP Auditor
Pharmuni GMP Device Qualification
Pharmuni Smart Data Security
Pharmuni Supplier Management
Harvard Business Connected Manager
Vorest AG Computer System Validation
TÜV Certified Quality Representative
TÜV Rheinland Group
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