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The Biotech Quality Group
- QA Consultant
Bruxelles
2013
THE BIOTECH QUALITY GROUP – Solution design – Bruxelles
(1 month)
Context and mission:
Support BQG solution design program
Roles and responsibilities:
Led a benchmarking analysis on all past Quality by Design publications - methodology, tools, processes.
Created knowledge packages on the following topics:
• Production in Aseptic environment,
• GmP & Regulatory requirements on Clothing systems for sterile environment.
• Analytical method transfer.
• Deviations & CAPA management.
• V-Cycle implementation
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Baxter International
- Quality Associate III
Maurepas
2014 - maintenant
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In a career transition
- In a career transition
2014 - 2014
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GlaxoSmithKline
- Project Manager
Marly-le-Roi
2014 - 2014
Maturity Diagnostic - Backlog CAPAs & Deviations
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The Biotech Quality Group
- Business manager
Bruxelles
2013 - 2014
Caroline is a manager for The Biotech Quality Group.
Caroline stepped into the professional world by working in a pharmaceutical company in the area of Brussels where she evolved as a Cleaning Validation Coordinator.
She has strong interpersonal skills, and an energetic and adaptive behavior. She is keen on showing great capabilities to work in multicultural teams, acting as a positive change driver.
At BQG, Caroline is in charge of consultants and clients relationship management in Wallonia and a part of Flanders area. She constantly aims at ensuring the delivery of customized added-value services for the client and for BQG.
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Lonza
- Cleaning validation coordinator
2012 - 2013
Department: Operational Excellence and Industrialization
--> Writing of cleaning validation documents:
- Process Validation Master Protocols
- SOPs
- Process Validation Protocols
- Process Validation Reports
--> Implementation and optimization of the swabbing sampling method in the lab:
--> In charge of the writing of all related documentation
- PVPM: validation of swabbing conditions
- PVP: Operators qualification
- Specific PVPs and associated PVRs
- SOP swabbing
--> In charge of the qualification of all operators of the Upstream Production, to the swabbing sampling technique
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Intezyne Technologies
- Junior Engineer
2011 - 2011
July 2010– January 2011 (7 months)Tampa/St. Région de Petersburg, Floride , États-Unis
Development and characterization of poly(D/L Glu-DET) polymers for non-viral nucleic acid delivery
- Polymers physicochemical characterization : Dynamic Light Scattering, transmission electron microscopy, agarose gel analysis, Gel permeation Chromatography, Nuclear magnetic resonance, Acid titration experiments
- Gel retardation assays, Ethidium Bromide exclusion assays
- Cell culture, Evaluation of in vitro transfection ability on human colon adenocarcinoma cancer cells (HCT-116) and cytotoxicity, confocal microscopy, DNA labelling experiments
- Biological characterization of polyplexes: Salt spin experiments
- Polymer PEGylation (Addition of NHS-PEG)
- Animal experiments: blood uptake (rats), nude mice (imaging)
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Lonza
- QA Consultant
2011 - 2011
Context and mission:
1) Writing of Product Annual Review Report (APRR) using an old template.
2) Creating and implementing a new optimized APRR template.
Roles and responsibilities:
Consultant in Quality Assurance
(Intervention date: Oct-2011 to Dec-2011 – duration: 3 months):
The writing of 4 APRRs using a legacy template, requiring:
- English skills
- Knowledge in Active Pharmaceutical Ingredients guidelines and documentation:
o ICH Q7: Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients – Subpart 2.3 “Product Quality Review”
o 21 Code of Federal Regulations (USA) Parts 210 & 211, Records and Reports: General Requirements.
o Internal procedures
- Knowledge in various documentation systems existing
o TrackWise for the management of deviations, change requests and CAPAs.
o DMS (The Documentation Management System) used for the management of most of the controlled documents (SOPs, MBRs, analytical methods, stability programs…).
o LIMS (The Laboratory Information Management System) used for the management of material specifications and their release testing.
Actions for the creation and implementation of a new APRR template:
- Contributed to “an improvement APRR process” workshop organized by The Biotech Quality Group
- Led investigations in Quality Assurance, Regulatory affairs, Quality Control, manufacturing teams in order to point out problems such as the non homogeneous use of statistics,
- Led statistics formation plan (Dixon test, H0 vs H1),
- Updated and writing of the APRR internal SOP,
- Wrote a new APRR template introducing particularly topics concerning the evaluation of CAPAs (required by ICH Q9) and risk management.
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Medesis Pharma
- Junior Engineer
2010 - 2010
June 2009– August 2009 (3 months)Baillargues, France
Delivery of Oligonucleotides and short interfering RNA (siRNA)
- Quality Controls
Confocal microscopy, fluorescent microscope, dosages using spectrophotometers
- Parmacological animal experiments
IV, IP, euthanasia, heart punctions, organs uptake
- Quality Assurance
GLP, process development
