ALEXIA BIGNON
QASCV Specialist
35 years old
Driving License
Professional Status
Employed
Available
About Me
Experienced professional in computer system validation for over 7 years. I am currently working as a QACSV specialist for Univercells.
I have a strong background in the pharmaceutical industry and have developed experience in the medical device field.
I strongly believe that good communication and a positive attitude are mandatory in the workplace.
I have many interests such as yoga, meditation, board games, video games, drawing and so on!
I have a strong background in the pharmaceutical industry and have developed experience in the medical device field.
I strongly believe that good communication and a positive attitude are mandatory in the workplace.
I have many interests such as yoga, meditation, board games, video games, drawing and so on!
QA CSV Specialist
Univercells
Since February 2022
Act as a guide in System Validation of Software as a service (Saas) tools/cloud applications, Data Integrity, 21 CFR Part 11 Compliance (ER/ES), Audit Preparation and Support, Data Migration, and Release and Change Management Process.
Involved in the overall development and maintenance of GxP-related computerized and automated system lifecycle documentation, from business process description through system retirement.
This includes:
- Validation (Master) Plans
- User Requirements Specifications
- Configuration, Functional, and Design Specifications
- Testing Protocols (IQ/OQ/PQ/UAT)
- Detailed risk assessment reports
- Requirements traceability matrices
- Validation Summary Reports
- SOPs
- Change Control Documentation
- Investigate validation discrepancies, drive deviation management.
- Contributing to best-practices for system validation including Computer System Validation (CSV) training and workshops.
- Validation (Master) Plans
- Audit
Developed a new postal audit template.
Working with the supplier audit department to audit IT-related suppliers. - SAP, Master Control, Spreadsheets
IT Practice partner
Caduceum
January 2021
to December 2021
- Defined the strategy for the development of skills/jobs/expertise of the Practice.
- In conjunction with the Business Managers, participated in the development of activities related to the Practice
- Participated in the technical and regulatory watch on the Practice area(s)
- Participated in the animation of the Practice
- Consultant for Pharmaceutical and Medical Devices companies on Computer System Validation and Quality Assurance topics.
- Performed assessments based on audit methodology for topics related to the validation of IT systems, such as review of validation strategy, regulatory compliance and completeness of procedures.
- Supervised the team of consultants in IT practices
Review of missions, follow-up with the client, identification of future missions of the consultants, training and preparation of exchanges with the client.
QUALITY ASSURANCE MANAGER
DBV Technologies
July 2019
to November 2020
- Quality Assurance Computerized System Validation
- Risk assessment evaluation, Exchange with suppliers ,writting Gap Analysis, Review of the URS, writting validation protocols, redaction of validation plans, writting Traceability Matrix, writting test sheets and approval of test sheets and reports.
- IT Business Quality Representative
Change Advisory Board member, IT Demand Committee member, GxP Evaluation of Systems and Meetings organization on on-going topics to ensure actions follow-ups. - Operational QA
CAPA, Deviation and change control follow-ups
KPIs definition
Meetings organization on on-going topics to ensure actions follow-ups. - Audit
- Working with the supplier audit department to audit IT-related suppliers.
- Audit
- Manager
Management of an intern
CSV CONSULTANT
LFB
December 2018
to June 2019
- Remediation 21 CFR part 11 of the Quality Control (Empower 3, Gen5, Omnic, Picta 1.7) and Supply Chain (TempTale) softwares to meet GxP's regulatory needs using a risk-based approach.
- Computer Validation
- Organized and led project meetings, Risk assessment evaluation, Exchange with suppliers, Wrote Gap Analysis, Wrote the URS,
Wrote validation protocols, Wrote the validation plans, Wrote Traceability Matrix, Wrote test sheets and Approved test sheets and reports.
CSV CONSULTANT
Servier
October 2018
to November 2018
- Migration of the ARGUS base from Shire to Servier. Execution of test case on Argus base within the framework of SHIRE pharmacovigilance data integration.
- Activities / Deliverables :
- Test execution
- Management and follow-up of anomalies.
- Test execution
CSV CONSULTANT
COOPER
July 2018
to August 2018
- WMS validation
- Participated in validation of the WMS software upgrade to meet GxP's regulatory needs using a risk-based approach.
- Activities / Deliverables :
- Performed the risk analysis using supplier documentation and elements of the Initial Validation file.
- Exchanged with suppliers.
- Participation in project meetings.
- Proofreading validation quality.
- Evaluated quality risks using GMP/GDP regulations.
- Needs assessment
- Performed the risk analysis using supplier documentation and elements of the Initial Validation file.
CSV CONSULTANT
SANOFI (Manufacturing)
March 2018
to June 2018
- Validation Expert
Participated in the QC equipment remediation project, data integrity issues and data integrity verification program.
Assisted QC teams on ongoing and new validation projects.
Participated in the migration of Empower within the Caducée project (PUMA methodology application) and in the migrations of small QC applications (softmaxpro, WinKQCL,...). - Quality Representative
Participated in the evaluation of change controls.
Reviewed key documents (validation plan/report, authorization for use, criticality assessment, risk assessment).
Evaluated non-conformities.
Responsible for methodology and IT systems regulatory compliance . - GxP Expert
Conducted periodic review of regulated software, Exchanged with suppliers,
Participated in project meetings, Decision making on methodology, Led risk assessment meetings and proofreading on validation documents. - Management
Followed-up and defined consultant's actions for validation activities
IS VALIDATION CONSULTANT
SANOFI (R&D)
November 2015
to February 2018
- AGILE methodology
- Provided expertise and advice to project teams on computerised systems validation activities to meet GxP's regulatory needs using a risk-based approach.
Coordinated risk assessment and ensured that validation activities are performed based on the assessed risks. Worked on WISE (Worldwide Integrated SaaS Environment) and its satellite applications. Participated in the migration of Empower within the Caducée project and migration from CTP to "CeDOC-PHARMA" (eTMF). - Validation Expert
- Responsible for methodology and regulatory compliance of GxP IT systems, Carried out the periodic review of regulated software,
Exchanged with suppliers, Participated in project meetings, Decision-making on methodology, Participated in risk assessment.
Proofreading quality validation. - Quality Representative
- Participated in change control evaluation, Reviewed key documents (validation plan/report, authorization for use, criticality assessment, risk assessment), Opened of CAPAs and ensured their follow-up, Evaluated non-conformities, Trained project actors to the methodology.
QUALIFICATION VALIDATION COORDINATOR
MEDA Manufacturing
January 2014
to September 2015
- Computer Validation
- Resumption of the validation activity of the site's computerized systems with assistance on equipment qualification projects.
Implementation of a degraded mode of use of a washer as well as the integration of a new washer. - Use of quality tools
- FMECA: Management of flows and assessment of safety and product risks on implementation of a degraded mode
- ISHIKAWA: 5M gap analysis
- PDCA: Project breakdown via the Deming wheel defining the progress plan and expectations. Work on retroplanning in the form of Gantt
- FMECA: Management of flows and assessment of safety and product risks on implementation of a degraded mode
- Quality Representative
- Participated in FAT/SAT as Quality Representative, Project meetings animation, Exchanged with suppliers.
Opened and ensured follow-up of Change control,CAPA and Deviation .
Wrote protocols and test sheets (IQ, OQ, PQ), Evaluated supplier tests, wrote/evaluated deviations and wrote reports for laboratory and production equipment.
Participated in regulatory inspections (FDA, ANVISA, ANSM) and supplier audits. - Project Management
- Planned requalifications and new software implementations requiring qualifications with the expected deadlines.
Used standard quality tools : FMECA (according to GAMP5), ISHIKAWA, implementation of PARETO on software QP, PDCA, Gantt, etc...
Wrote protocols (IQ, OQ, PQ), Evaluated Tests.
Wrote and/or evaluated non-conformities
Wrote validation reports
Evaluated software criticality according to different questions used to target their impact.
Worked on the URS to target criticality and exchanged with the various impacted departments on the scope of software.
QUALIFICATION/VALIDATION HIGHER TECHNICIAN
HTL Biotechnology
October 2011
to October 2013
- Cleaning Validation
- Equipment Qualification
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English
Advanced
-
French
Expert
-
Office pack
Advanced
-
Veeva Vault QualityDocs
Advanced
-
Documentum
Advanced
-
ServiceNow
Good
-
UL Compliance Wire
Good
-
Empower
Good
-
ArisG
Intermediate
-
QuBES
Intermediate
-
HMI
Intermediate
-
SAP
Intermediate
-
GMP
Expert
-
GLP
Good
-
GCP
Advanced
-
21 CFR part 11
Expert
-
21 CFR part 820
Advanced
-
ISO 13485
Good
-
ISO 2859
Good
-
IEC 62304
Good
-
GAMP5
Expert
-
CAPA Management
Expert
-
Quality management
Expert
-
Deviation management
Expert
- Change Control Management
-
PDCA
Expert
-
Risk Analysis
Expert
-
Five Ws
Advanced
-
Ishikawa
Expert
-
DMAIC
Expert
-
Lean 6sigma
Good
-
PARETO
Good
