Burcu Passiz - QA Validation/Qualification (BioNTech)

Q: Where is Burcu based?

Burcu is based in Lampertheim, Germany .

Q: What languages does Burcu speak?

Burcu speaks the following languages: German (Native), English (Advanced), Turkish (Advanced) .

Q: How many years of experience does Burcu have?

Burcu has at least 11 years of experience. During this time, Burcu has worked in at least 8 different roles and for 4 different companies . The average length of individual experience is 1 year and 2 months . Note that Burcu may not have shared all experience and actually has more experience.

Q: What is Burcu's latest experience?

Burcu's most recent position is QA Validation/Qualification (BioNTech) at Burcu Passiz Consulting .

Q: What companies has Burcu worked for in recent years?

In recent years, Burcu has worked for Burcu Passiz Consulting , Altran GmbH (Capgemini) , and Altran GmbH .

Q: Which industries is Burcu most experienced in?

Burcu is most experienced in industries like Pharmaceutical , Professional Services , and Chemical .

Q: Which business areas is Burcu most experienced in?

Burcu is most experienced in business areas like Quality Assurance , Project Management , and Production . Burcu also has some experience in Information Technology .

Q: Which industries has Burcu worked in recently?

Burcu has recently worked in industries like Pharmaceutical and Professional Services .

Q: Which business areas has Burcu worked in recently?

Burcu has recently worked in business areas like Quality Assurance , Information Technology , and Project Management .

Recommended expert

Lampertheim, Germany

Experience

Apr 2024 - Sep 2024

6 months

QA 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 8 months

Data 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 months

Validation 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 months

Frankfurt, 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 months

Frankfurt, 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 months

Frankfurt, 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 month

Frankfurt, 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 months

Frankfurt, 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 month

Lorsch, Germany

GMP Trainee

Prisman GmbH

Optimizing process workflows for the production of disinfectants

Industry Experience

See where this freelancer has spent most of their professional time.

Experienced in Pharmaceutical, Professional Services, and Chemical.

Pharmaceutical

Professional Services

Chemical

Business Area Experience

See which departments and functions this freelancer has contributed to most.

Experienced in Quality Assurance, Project Management, Production, and Information Technology.

Quality Assurance

Project Management

Production

Information Technology

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

Native

English

Advanced

Turkish

Advanced

Education

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

Statistics

Experience

Total positions 9

Experience in Pharmaceutical 10 y

Avg length 1 y 3 m

Longest experience 3 y

Global Experience

Countries worked in 1 (Germany)

Primary country Germany

Expertise

Recent roles QA Validation/Qualification (BioNTech), Data Integrity Consultant (Sanofi), Validation Manager (GSK Vaccines)

Main industries Pharmaceutical, Professional Services, Chemical

Main business areas Quality Assurance, Project Management, Production

Qualifications

Highest degree Bachelor

Certifications earned 7

Profile

Created

August 2024

Last Update

February 2025

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Burcu based?

Burcu is based in Lampertheim, Germany.

What languages does Burcu speak?

Burcu speaks the following languages: German (Native), English (Advanced), Turkish (Advanced).

How many years of experience does Burcu have?

Burcu has at least 11 years of experience. During this time, Burcu has worked in at least 8 different roles and for 4 different companies. The average length of individual experience is 1 year and 2 months. Note that Burcu may not have shared all experience and actually has more experience.

What roles would Burcu be best suited for?

Based on recent experience, Burcu would be well-suited for roles such as: QA Validation/Qualification (BioNTech), Data Integrity Consultant (Sanofi), Validation Manager (GSK Vaccines).

What is Burcu's latest experience?

Burcu's most recent position is QA Validation/Qualification (BioNTech) at Burcu Passiz Consulting.

What companies has Burcu worked for in recent years?

In recent years, Burcu has worked for Burcu Passiz Consulting, Altran GmbH (Capgemini), and Altran GmbH.

Which industries is Burcu most experienced in?

Burcu is most experienced in industries like Pharmaceutical, Professional Services, and Chemical.

Which business areas is Burcu most experienced in?

Burcu is most experienced in business areas like Quality Assurance, Project Management, and Production. Burcu also has some experience in Information Technology.

Which industries has Burcu worked in recently?

Burcu has recently worked in industries like Pharmaceutical and Professional Services.

Which business areas has Burcu worked in recently?

Burcu has recently worked in business areas like Quality Assurance, Information Technology, and Project Management.

What is Burcu's education?

Burcu holds a Bachelor in Medical Technology from Hochschule Koblenz.

Does Burcu have any certificates?

Burcu has 7 certificates. Among them, these include: GMP Auditor, GMP Device Qualification, and Smart Data Security.

What is the availability of Burcu?

Burcu is immediately available part-time for suitable projects.

What is the rate of Burcu?

Burcu's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.