Projects

Since 09/2023                 Remediation Project Data Integrity Audit Trail
QA Audit Trail Expert, Alvotech, Reykjavik, ISL
Update of audit trail review process.
Training and guidance of the QA AT team.
Support Win 10/Win 11 GxP rollout.

06/2023                          Qualification of high purity media
Qualification expert, Ferring GmbH, Kiel, DE
IOQ of high purity media

03/2023 – 07/2023          Team Lead Operational Technology
Head of Operational Technology, AmpTec (Merck KGaA), Hamburg, DE
Design, ordering, installation, operation and maintenance of equipment at two production sites.
Establishment, implementation and maintenance of qualification and validation processes for GMP-compliant system operation
Support in case of deviations, change control, CAPA

05/2022 – 04/2023          Qualification of production and filling lines
Qualification expert, Vet Pharma (MSD), Friesoythe, DE
Design qualification (DQ, URS, FRS, FAT, SAT) and commissioning
Risk assessments as well as IQ, OQ and PQ
CSV in cooperation with IT and process automation

03/2022 – 05/2022          Data Integrity Packaging equipment
Qualification expert, Catalent, Schorndorf, DE
Project work Evaluation of data integrity of packaging plants (solid dosage forms) and derivation of recommendations for action

08/2021 – 04/2022           Project Management Equipment Qualification 
Qualification Expert, GSK, Dresden, DE
Project management for qualification and implementation of new laboratory equipment
Full CSV lifecycle considering GxP, 21 CFR 11, Annex 11.

01/2021 – 12/2021           Program Lead Win10 Lab Rollout
CSV Expert Lab, Sanofi, Frankfurt, DE
Coordination of Win 10 rollout to 100+ lab systems and corresponding validation activities according to GAMP 5, 21 CFR part 11, Annex 11, GDP
Data Integrity expertise (Gaps, Risks, Mitigation and Remediation).

01/2021 – 09/2021           CSV Engineer
CSV Lead Expertise, Alvotech GmbH, Hannover, DE
Ensuring GMP compliance (Annex 11, GAMP5 etc.).
Implementation, maintenance, and improvement of corresponding SOPs.
Maintaining a validated state of computerized systems.

09/2020 – 10/2020           Automation Engineer
Equipment FAT, MSD Carlow, IE 
Review of test documentation created by suppliers.
Execution of equipment FAT
Review and approval of the qualification documentation.

06/2020 – 08/2020           Senior CSV Engineer (Automation)
CSV Lead, Biogen, Solothurn, CH
Oversee and perform CSV activities 
Create / revise test documentation
Implementation of the global CSV program.

11/2019 – 08/2020           CSV Lead
CSV Lead expertise, MSD AH Danube Biotech, Krems, AT
Review and approval of supplier provided test documentation. 
Support for management of Software FAT execution 
Development of high-level SDLC deliverables (QAPs, QASRs etc).

09/2018 – 12/2019           Project Management IT / CSV expert
Project Manager IT CSV, Ethicon, JnJ, Norderstedt, DE
Identify IT dependent systems and execute project management
Production IT systems: ERP/JDE, MES, Labeling, LIMS
Change Management: coordinate changes, define resources

08/2019 – 10/2019           Senior CSV expert
Subject Matter Expert CSV, Mucos Pharma, Berlin, DE
Execution of gap assessment and development of mitigation strategy
Assess global SOPs and transfer applicable SOP to local QMS,
Validation of computer systems.

01/2018 – 03/2019           Expert IT System Validation and Management 
Validation Specialist, Novartis, Basel, CH 
Coordination of validation activities regarding laboratory systems
Writing SOPs, change management, qualifications, and migrations,
performing IQ, OQ and PQ

11/2017 – 12/2018           Project Manager CSV, database validation
CSV Lead, (Octapharma), Hanover, DE
Creating the VP, UFRS, RA, TRM, VR (GMP Annex 11)
Training and development of team members

02/2016 – 12/2017           Computer System Validation & Equipment Qualification
Interim Manager CSV, Vet Pharma (MSD), Friesoythe, DE
Validation of laboratory equipment and corresponding management software
Performing data integrity assessments, Supplier qualification

02/2017 – 05/2107           CSV QlikView BI Dashboard
Validation Manager CSV, Boehringer, Dortmund, DE
Creation of requirement specifications and test cases
Review and revision of technical documentation (ISO 13485).

08/2015 – 12/2015           Technical Documentation, Quality Management
Technical Writer, DePuy Synthes, Balsthal, CH
Document Change Control / Versioning
Creation and maintenance of Quality Progress Reports & QSM Reports

04/2015 – 08/2015           Design & Revision of master production records
Medical Writer, Rentschler Biotechnologie, Laupheim, DE
Development and revision of master production records
Revision of flowcharts (MS Visio). 

03/2015 – 07/2015           Computer System Validation, SAP BW
Validation Responsible, CSL Behring, Marburg, DE
Initial risk assessment and validation plan acc. to GMP Annex 11
Revision of change and test procedures

04/2014 – 12/2014           Retrospective CSV, legacy applications
Project Manager, DePuy Synthes, Hägendorf, CH  
Leading a team of up to 4 technical writers
Retrospective validation of Access databases and Excel workbooks

07/2013 – 12/2013           FDA QSR – Legacy Management Reviews
Quality Regulatory Consultant, Synthes, Mezzovico, CH  
21CFR820: Legacy Management Reviews
Highlighting quality risks and designing/implementing mitigation activities

05/2013 – 10/2013           Computer System Validation, QlikView BI server
Technical Writer, CSL Behring, Marburg, DE
Developing and executing validation plan according to GMP Annex 11
Creating corresponding DQ/IQ/OQ documents

04/2012 – 04/2013           Business Development Manager
Project Management, Wick Hill GmbH, Hamburg, DE
Preparation of business plans, analysis, and forecasts