Kasia BIRON
Eragny sur Oise
Summary
With a proven track record at SGS Health Science, I spearheaded quality assurance and team leadership, enhancing GMP compliance and customer satisfaction. Knowledge in ISO 17025:2017 and adept at driving project success through effective team management, my approach has consistently led to significant process improvements and regulatory adherence.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Quality Assurance Manager
SGS Health Science
Paris
10.2020 - Current
- In-depth experience in Pharma GMP inspections of ANSM, ANSES (French authorities), and Turkish authorities.
- Preparation, execution, and follow-up of customer, internal, and external audits in the GMP and ISO 17025:2017 environments.
- Implementation of QMS and DMS (Quality and Document Management System), assuring management reviews, change control, approval, edition, and revision of the SOPs, work instructions, and methods.
- Approval of certificates (CoA/RoA) under the responsibility of the Qualified Person.
- Approval of chemistry and microbiology analytical transfer/validation protocols, reports.
- Managed customer complaints and non-conformance issues, ensuring swift resolutions, and maintaining high levels of customer satisfaction (CAPA system).
- Management and follow-up of the regulatory guidelines' updates (USP, EU, and JP pharmacopoeias, ICH Q, ISO, and GMP).
- Implementation of the LEAN Management.
- Provided leadership, insight and mentoring to newly hired employees
Analytical Project Manager
CENEXI Services
Paris
09.2018 - 09.2018
- Team Management (10 technicians and engineers in the Analytical Development Department).
- Conducted regular status meetings with internal teams and external partners to track progress against established milestones.
- Drove continuous improvement of project delivery process by providing strong leadership.
- Development and validation of the chromatographic methods (liquid, gas, ion exchange, and size exclusion chromatography).
- Management of GMP Quality Events (OOS, deviations, and CAPAs).
- Management of stability studies according to the ICH Q guidelines.
- Participation in LEAN Management.
Analytical Development Manager
DBV Technologies
Paris
02.2018 - 09.2018
- Team Management (Set objectives for the team of five technicians and engineers, based on the project's goals; provided feedback, and took corrective action when needed.)
- Development of chromatographic methods for the quantification of the protein in the innovative patch technology of the clinical-stage biopharmaceutical company.
- Knowledge of CMC drug development contributes to the regulatory files.
- Monitoring of CMC development plans, ensuring compliance with deadlines, and regulatory requirements.
Analytical Project Manager
LFB Biomedicines
Paris
07.2017 - 02.2018
- Team Management Experience.
- Management of stability studies according to the ICH Q guidelines.
- Approval of the reports summarizing stability studies.
Polymer Chemist
Akzo Nobel ICI Paints
Slough
10.2011 - 10.2012
- Analyzed samples using chromatography, spectroscopy, and other analytical techniques.
- Researched existing scientific literature to identify trends in the field of chemistry and inform ongoing global research projects.
- Performed polymer sytheses.
- Analyzed data from laboratory experiments using statistical methods to verify accuracy and reliability of results.
Education
Ph.D. - Chemistry - Synthesis And Analysis of Organic Matter Analogs
Sorbonne University
Paris, France01.2016
Master - Analytical Chemistry - Characteristics of different types of collagens
Birkbeck, University of London
London, UK01.2011
Master - Chemical Engineering - Synthesis and analysis of antibacterial polymers
Technical University of Lodz
Lodz, Poland01.2008
Skills
- Pharma GMP
- GMP inspections
- ISO 17025: 2017
- QMS
- DMS
- Complaint handling
- CAPA system
- Change control
- SOPs
- Work Instructions
- Analytical transfer
- Validation protocols
- Team Management
- Regulatory guidelines
- USP
- EU pharmacopoeias
- JP pharmacopoeias
- ICH Q
- GMP events
- Project Management
- CMC Drug Development
- Stability studies
- LEAN SIX SIGMA
- Chromatography techniques
- Spectroscopic techniques
Certification
- Green Belt LEAN Six Sigma, Paris
- Microsoft Office, London
Training
- Project Management, CEFIRA, Paris
- Validation of analytical methods, CEFIRA, Paris
Languages
- English, bilingual
- French, bilingual
- Polish, mother language
Personal Information
- Age: 42
- Nationality: French & Polish
- Driving License: B
- Marital Status: Married
Timeline
Quality Assurance Manager
SGS Health Science
10.2020 - Current
Analytical Project Manager
CENEXI Services
09.2018 - 09.2018
Analytical Development Manager
DBV Technologies
02.2018 - 09.2018
Analytical Project Manager
LFB Biomedicines
07.2017 - 02.2018
Polymer Chemist
Akzo Nobel ICI Paints
10.2011 - 10.2012
Ph.D. - Chemistry - Synthesis And Analysis of Organic Matter Analogs
Sorbonne University
Master - Analytical Chemistry - Characteristics of different types of collagens
Birkbeck, University of London
Master - Chemical Engineering - Synthesis and analysis of antibacterial polymers
Technical University of Lodz
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