Laetitia Muszkieta
IS Business Analyst for QC and R&D activities
Scientific Expert
Double Competency
Quality Control and Manufacturing
Solution Analysis
Non-Product Software Definition
41 years old
Driving License
Lentilly (69210) France
Employed
Open to opportunities
Based on my professional experiences , I have acquired strong knowledge in the design of diagnostic products. These knowledge are including the product conception phase involving R&D activities but also phases required for the delivery of commercial product.
Today I am acting as IS Business Analyst for the R&D and QC activities within bioMerieux. Acting as consultant, I support different business actors in the definition of their requirements and the conception of application adapted to their activities. Thus, I am involved within projects as team player with good communication skills, organization, flexibility, respecting time lines,supporting business departments and enforcing my expertise on diagnostic industry and information systems.
It is in this way that I bring my expertise on the development of new efficient, accurate, and innovative computerized solutions in the respect of the quality guidelines inherent to the diagnostic domain.
Today I am acting as IS Business Analyst for the R&D and QC activities within bioMerieux. Acting as consultant, I support different business actors in the definition of their requirements and the conception of application adapted to their activities. Thus, I am involved within projects as team player with good communication skills, organization, flexibility, respecting time lines,supporting business departments and enforcing my expertise on diagnostic industry and information systems.
It is in this way that I bring my expertise on the development of new efficient, accurate, and innovative computerized solutions in the respect of the quality guidelines inherent to the diagnostic domain.
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English
Good
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French
Expert
- Definition and Prioritization of User Requirements (URS)
- Workshop et Brainstorming Organization
- Risk Analysis linked to the application development
- Choice of the Integrator after benchmark
- Wrinting of the Functional Requirement Specifications (FRS)
- Approval of the technical documentation linked to the application
- Wrinting and Execution of Verification testing activities
- Support Business Representatives in the Validation Phase
- Wrinting of the training sessions
- Reporting and Communication on activities
- Solution Implementation according to quality guidelines
- Apply NPS methodology and Change request process
- Partnership management (Sanofi, Biomérieux, Bioaster, Solution Integrator)
- Project Plan Definition and coordination
- Project Risk Management
- Budget Definition and Monitoring
- Quotation request
- 21CFR part 11 for Non-product Software
- GMP= Good Manufacturing Practices
- GCP= Good Clinical Practices
- Utilization of prediction softwares and databases for molecular design, and sequence comparison: BLAST, ClustalX, TMHMM, SignalP
- phylogeny: Genedoc, PhyML,
- Analysis of transcriptomic data: GeneData Analyst, EdgeR.
- Design of real time PCR probes: Primer express, molecular beacon
- Genetic map and cartography: Vector NTI
- Micro-organisms Culture (fungi, bacteria, yeast) in liquid and solid media, fermentor.
- Antifungal and Antobiotics suceptibilities
- Antifungal mode of action Analysis
- Phenotypic Characterization of mutated strain
- Immuno-labelling in situ.
- Cytokines dosages by ELISA method
- Cells culture
- Primary cells Isolation.
- Cytotoxicity Tests
- Molecular Design: Genetic construction and design of specific probes
- Nucleic Acid Extraction : ADN, ARN
- PCR Methods: Real-time PCR (Sybergreen, Taqman, Nested PCR), Double joint PCR, RT-PCR
- Genetic Transformation Processes (fungi, yeasts, bacteria)
- Southern/Northern/Western blots
- Transcriptomic Data Analysis
- Deletion Mutant Bank construction
