Recommended expert
Burcu Passiz
QA Validation/Qualification (BioNTech)
Experience
Apr 2024 - Sep 2024
6 monthsQA Validation/Qualification (BioNTech)
Burcu Passiz Consulting
- Review and release of validation documents, reports and standard operating procedures (SOP)
- Review and release of change controls
- Performing risk analyses and FMEAs
- Preparing qualification reports
- Performing periodic evaluations and creating RTMs
Aug 2023 - Present
2 years 6 monthsData Integrity Consultant (Sanofi)
Burcu Passiz Consulting
- Conducting data integrity gap assessments
- Creating documents related to data integrity
- Developing audit trail concepts
- Developing access management concepts
- Ensuring implementation of regulatory requirements for data integrity
May 2023 - Aug 2023
4 monthsValidation Manager (GSK Vaccines)
Burcu Passiz Consulting
- Planning, executing and completing process validations
- Preparing reports
- Creating Critical Risk Assessments (CRAs)
- Preparing validation protocols and reports
Jul 2022 - Apr 2023
10 monthsFrankfurt, Germany
Validation Manager (GSK Vaccines)
Altran GmbH (Capgemini)
- Planning, executing and completing process validations
- Preparing reports
- Creating risk assessments
- Implementing single-use systems
Jan 2022 - Jul 2022
7 monthsFrankfurt, Germany
Project Management Consultant (GSK Vaccines)
Altran GmbH
- Implementing a new document management system (Veeva Quality Docs)
- Creating a project plan
- Monitoring and coordinating project milestones
- Training and advising users
- Liaising with global project teams
Feb 2020 - Dec 2021
1 year 11 monthsFrankfurt, Germany
3R Change Manager (GSK Vaccines)
Altran GmbH
- Coordination, execution, and completion of change requests to reduce animal testing (replacement, reduction, refinement)
- Performing CSV including report creation
- Taking over project coordination
- Communication with external project teams
Feb 2017 - Feb 2020
3 years 1 monthFrankfurt, Germany
Process Specialist (GSK Vaccines)
Altran GmbH
- Certified Change Manager and mentor
- Coordination, planning, and execution of change requests for vaccine manufacturing
- Creation of risk assessments and qualification documents
- Leading team change meetings
- Preparing and presenting at inspections
- Creation of KPIs and CAPAs
- Creation and initiation of deviation reports
- Management of project teams
Jun 2016 - Feb 2017
9 monthsFrankfurt, Germany
IT Consultant (GSK Vaccines)
Altran GmbH
- Performing data and system migration to the new IT infrastructure
- GMP-compliant documentation of the migration of GxP lab systems
- Reviewing GMP-compliant documentation
Mar 2015 - Mar 2016
1 year 1 monthLorsch, Germany
GMP Trainee
Prisman GmbH
- Optimizing process workflows for the production of disinfectants
Skills
Qualification/validation
Data Integrity
Csv
Gxp Auditing / Audit Management
Qa Management
Change / Deviation / Capa Management
Gmp Processes
Project Management
Trackwise
Veeva
Lims
Sap R/3
Documentum
Languages
German
NativeEnglish
AdvancedTurkish
AdvancedEducation
Sep 2011 - Dec 2014
Hochschule Koblenz
Bachelor of Science, Medical Technology · Medical Technology · Koblenz, Germany
Sep 2010 - Jul 2011
Eberhard Gothein Schule, Wirtschaftsoberschule
University of Applied Sciences Entrance Qualification · Mannheim, Germany
Certifications & licenses
GMP Auditor
Pharmaaudit
GMP Device Qualification
Pharmuni
Smart Data Security
Pharmuni
Supplier Management
Pharmuni
Connected Manager
Harvard Business
Computer System Validation
Vorest AG
TÜV Certified Quality Officer
TÜV Rheinland Group
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