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EX-01
Rigor
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Validate a system end to end under 21 CFR Part 11 & 820, using a risk-based approach.
Acceptance criterion
Ability to manage the complete validation lifecycle of computerized systems, from URS to user acceptance testing (UAT), under 21 CFR Part 11 & 820 and GAMP 5, producing all regulatory deliverables.
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Evidence (career excerpt)
- 10+ systems validated under Part 11 & 820: 2 electronic document management systems (EDMS), including a customized Confluence EDMS (electronic signature, versioning, approval workflows), R&D, production and clinical trial software, Jira (CAPA), Git/GitHub
- End-to-end deliverables: URS/FRS/SRS, validation plans (including migrations), risk analyses using failure mode and effects analysis (FMEA), IQ/OQ/PQ protocols, 50+ test scripts, traceability matrices, reports, user acceptance testing (UAT)
- Electronic device history records (DHR) (21 CFR 820.184, pre-QMSR): management of the project to move them into the EDMS, validation, work instruction
- Method: sprint-based qualifications, regression testing scope adjusted after defects, approval of OQ/PQ scripts, 21 CFR Part 11 coverage in URSs
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Pass
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EX-02
Documentation rigor
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Stand up to audit scrutiny.
Acceptance criterion
Demonstrate regulatory compliance in internal and notified body audits with no major discrepancies, through rigorous follow-up of changes, deviations and procedures.
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Evidence (career excerpt)
- Audits with no major nonconformity: systems presented during internal audits and the DEKRA notified body audit (CE marking)
- Day-to-day quality: change control (impact assessment), validation discrepancies, deviations and nonconformities (root cause, criticality, re-execution) through to closure, procedure (SOP) updates; scripted testing complemented by exploratory testing upon receipt of deliverables
- Maintaining the validated state: data integrity (ALCOA+), audit trails, periodic reviews, checks of Squash TM reports; supplier assessment and qualification (including a web service provider) with QA/RA; document templates; co-approval with R&D of deployments with no product impact
- Documentation rigor: retrospective record reviews, versioning and traceability rules
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Pass
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EX-03
Precision
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Find what the script misses.
Acceptance criterion
Ability to complement formal execution with critical exploratory testing and improve legacy systems through retrospective specification.
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Evidence (career excerpt)
- Projects led independently: Squash TM validation, EDMS enhancements for production, retrospective specification of the EDMS to fix legacy defects; retrospective specification of the Jira FMEA configuration; configuration of validation project workflows (Confluence and Jira)
- Day-to-day quality: change control (impact assessment), validation discrepancies, deviations and nonconformities (root cause, criticality, re-execution) through to closure, procedure (SOP) updates; scripted testing complemented by exploratory testing upon receipt of deliverables
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Pass
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EX-04
Technical precision
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Read code, write tests, manage testers.
Acceptance criterion
Combined skills in software development, technical acceptance test team management and test automation to work with technical and QA teams.
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Evidence (career excerpt)
- Online appointment booking application for doctors (MVC, database, responsive); business-side project support for a client: product backlog and detailed specifications written with the project manager, acceptance test strategy and scenarios, functional and regression testing, test reports
- Test Lead: remote management of 4 to 6 testers in Morocco (offshore team of about ten people), across 2 projects
- Test strategy and methodology of the Quality team; Squash TM repository, defect analysis (Jira), execution reports
- Methodology: wrote a Squash TM guide (repository, reusable test cases, campaigns) and trained the testers
- Acceptance testing: effort estimation, test data sets, integration scenarios, functional documentation
- Test automation, self-taught (Katalon Studio, TestComplete)
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Pass
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EX-05
Creativity
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Build what does not yet exist.
Acceptance criterion
Ability to structure a new activity, recruit and manage a dedicated team, design suitable test methods and lead cross-functional projects.
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Evidence (career excerpt)
- Management and cross-functional work: CSV team of 3 (recruitment with job descriptions and case studies, supervision, training); management of the website project for CE marking (requirements, IQ/OQ/PQ acceptance testing, coordination of the various disciplines involved; MDR 2017/745, electronic instructions for use (e-IFU), ANSM (French medicines agency) and GDPR requirements applied); task allocation to the IT infrastructure service provider; administration of tools (Confluence, Jira, Squash TM, Dolibarr) and training of user teams (including quarterly EDMS sessions, knowledge assessment, traceability of user authorizations) (R&D, production, clinical, QA/RA), materials in French and English
- Electronic device history records (DHR) (21 CFR 820.184, pre-QMSR): management of the project to move them into the EDMS, validation, work instruction
- Test strategy and methodology of the Quality team; Squash TM repository, defect analysis (Jira), execution reports
- Methodology: wrote a Squash TM guide (repository, reusable test cases, campaigns) and trained the testers
- Test automation, self-taught (Katalon Studio, TestComplete)
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Pass
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EX-06
Knowledge sharing
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Connect QA/RA, IT and business teams across languages.
Acceptance criterion
Teaching skills to train and align multidisciplinary teams (QA/RA, technical and business teams), and ease of communication in an international context.
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Evidence (career excerpt)
- Management and cross-functional work: CSV team of 3 (recruitment with job descriptions and case studies, supervision, training); management of the website project for CE marking (requirements, IQ/OQ/PQ acceptance testing, coordination of the various disciplines involved; MDR 2017/745, electronic instructions for use (e-IFU), ANSM (French medicines agency) and GDPR requirements applied); task allocation to the IT infrastructure service provider; administration of tools (Confluence, Jira, Squash TM, Dolibarr) and training of user teams (including quarterly EDMS sessions, knowledge assessment, traceability of user authorizations) (R&D, production, clinical, QA/RA), materials in French and English
- Project management
- Coordination of staff at trade shows and pitchside (hospitality staff, security staff, caterers): instructions, run of show, compliance with safety rules
- Trilingual guided tours: standard, technical and themed (theatrical) tours
- French language assistant in the United Kingdom (Oakgrove School, Milton Keynes, 2010 – 2011)
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Pass
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