Rosita Hoogenboom
Nieuwe-Wetering,The Netherlands
Summary
Accomplished Quality Management Professional experienced in GMP compliance and quality management systems. Enhanced operational efficiency through analytical thinking, LEAN process improvement, and effective communication skills. Focused on driving continuous improvement and maintaining high standards within the biotechnology sector.
Overview
16
16
years of professional experience
4
4
years of post-secondary education
Work history
QA Operations EU manufacturing coordinator (Sr. QA specialist)
Galapagos B.V.
Leiden
04.2024 - 09.2024
- DMU monitoring – Clinical batch review for connected DMUs
- Manage DMU training oversight
- Overall training oversight on SOP/ WI training items
- AOQ and APS/APV status oversight
- Manage change controls related to Master Quality Technical Agreements (MQTA) between current DMU’s and new Clinical Trial Site (CTS) locations
- Manage quality management attributes for DMU and Central Site activities: Deviations, CAPA’s and Change Controls
- SAP Key User for Quality Assurance team – including the UAT creation and execution for new SAP releases
- QA representative for any Kitting or SAP related items
- QA Support in Kitting batch execution for review and SAP release of kits
- QA representative for review and approval of Kit configuration updates
- SAP Kit BOM and Treatment BOM activation/ inactivation in SAP
- Manage quality management attributes for Kitting/ SAP and Supply Chain related activities: Deviations, CAPAs, Change Controls and Complaints
- Review and approval of Kitting, Supply Chain and SAP procedures
- QA representative for DMU Return shipments
- Logbook initiation for Finch site
Manufacturing GMP Specialist, Drug Product Development
Johnson & Johnson Innovative Medicine
Leiden
04.2020 - 03.2024
- Responsible for execution of Quality Root Cause Analysis Investigations (low/med/high), Corrective and Preventive Actions and Change Controls in Quality Management System
- Product Quality Complaint Investigations in PQMS system
- Maintaining departmental compliance and training requirements, in SUMMIT and Compliance Wire
- Arranging Purchase Orders
- Arranging GMP shipments EU/ US
- Setting up departmental SharePoint page(s), including the set-up of Microsoft forms and Microsoft Power-Automate
- Maintaining departmental KPI’s in Tableau
- (before Janssen Vaccines & Prevention B.V.)
Associate Scientist Analytical Development – Molecular and Bioassay
Johnson & Johnson Innovative Medicine
Leiden
06.2009 - 03.2020
- Responsible for the development, optimization, qualification and validation (including trouble shooting) of Molecular and Bioassay for release and stability testing as well as for the characterization purposes of vaccine products.
- Techniques: Infectivity assays, tests for effective inactivation, Residual Host Cell Protein, Western Blots, potency ELISA’s, Cell-culture
- Responsibility/ skills:
- Subject matter expert for several methods
- Writing SOP’s WI’s and TMD’s
- Writing of development plans/ reports and qualification plans/ reports
- Yellow belt, Continuous improvement projects
- Lab responsible, including KANBAN and 5S implementation
- Working under BSL-1, BSL-2 and BSL-2+ environment
- Work according GMP/ GLP conditions
- Organization and planning
- Providing training to departments in Leiden, Bern and Solna
- Working with deadlines
- Lead in laboratory refurbishment, setting up floor map and be the go-to person for all external contractors
- (before Janssen Vaccines & Prevention B.V.)
Sr. Technician QC PER.C6 Project
Johnson & Johnson Innovative Medicine
Leiden
11.2014 - 06.2016
- Technical specialist working on technology transfer of analytical methods for testing AdVac PER.C6 vaccine products.
- Responsibility/ skills:
- Writing and updating of standard operating procedures (SOP’s), work instructions (WI’s) and Installation Qualification/ Operating Qualification (IQ/ OQ)
- Writing technology transfer plans and reports
- Lead in laboratory refurbishment, setting up floor map and be the go-to person for all external contractors
- (before Janssen Biologics B.V.)
Jr. Technician QC – Raw materials (summer job)
Johnson & Johnson Innovative Medicine
Leiden
06.2008 - 08.2008
- Junior technician working in the raw materials department performing routine analysis.
- Techniques: Color & Appearance testing, Conductivity measurement, pH measurement, Pooling of raw materials, Preparation of solutions and reagents
- (before Janssen Biologics B.V.)
Education
Middelbaar Laboratorium Onderwijs Niveau 4 - Biotechnology
ROC Leiden/ Hogeschool Leiden
Leiden, The Netherlands 01.2005 - 01.2009
Skills
- Analytical thinking
- Communication
- GMP compliance
- Collaborative teamwork
- Adaptability to perform under deadlines
- LEAN Process Improvement and planning
- Quality Management System
- Good Manufacturing Practice (GMP)
- Biotechnology
- Root Cause Analysis
- Technical writing
COMPUTER SKILLS
- MS Word, MS Outlook, MS Power Point, MS Excel, MS Forms, MS Power-Automate, MS TEAMS
- ETS Trackwise, Veeva Vault Quality
- SharePoint
- Documentation system(s)
- Veeva Vault, TruVault, DocSpace, eFlow
- Training Management System
- SUMMIT, Compliance Wire
- Tableau
- SAP S/4 HANA, SAP Sustain
- GraphPad Prism
LANGUAGES
Dutch (Native)
English (Fluent)
REFERENCES
Available upon request
RELEVANT COURSES
- GMP meets AI – How to use Artificial Intelligence in Quality Assurance and Quality Control – ECA Academy
- Root Cause Investigation Kepner Tregoe - CoThink
- Validation of Analytical Test Procedures & Measurement – ECA Academy
- GMP Course – Hoge school Leiden
- Biosafety & Virology – Hoge school Leiden
- Insight training
- Scientific report writing - NOIW
- Company first aid team (BHV) – Veiligheidsinstituut/ G4S
- Effective communication
ADDITIONAL INFORMATION
Driver license B
INTERNSHIPS
- Intern – Molecular and Bioassay development
- Johnson & Johnson Innovative Medicine (before Janssen Vaccines & Prevention B.V.) | Leiden, The Netherlands | September 2008 – June 2009
- Project: Research and monitoring of different cell lines to define the effect on virus infectivity.
- Techniques: Cell culture, Tissue Culture Infectious Dose (TCID50), Q-PCR based Potency Assay
Timeline
QA Operations EU manufacturing coordinator (Sr. QA specialist)
Galapagos B.V.
04.2024 - 09.2024
Manufacturing GMP Specialist, Drug Product Development
Johnson & Johnson Innovative Medicine
04.2020 - 03.2024
Sr. Technician QC PER.C6 Project
Johnson & Johnson Innovative Medicine
11.2014 - 06.2016
Associate Scientist Analytical Development – Molecular and Bioassay
Johnson & Johnson Innovative Medicine
06.2009 - 03.2020
Jr. Technician QC – Raw materials (summer job)
Johnson & Johnson Innovative Medicine
06.2008 - 08.2008
Middelbaar Laboratorium Onderwijs Niveau 4 - Biotechnology
ROC Leiden/ Hogeschool Leiden
01.2005 - 01.2009