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!
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.
