ADAM Valérie (EFOR-CVO)
Compétences
Quality systems
- CAPA – Change control – Root cause analysis.
- Risk analysis.
- Documentation Management.
- Incoming Inspection (CoC, CoA, spécifications, temperature excursions label inspection).
- Batch Release.
- Updating and optimization.
Audit
- Regulatory compliance audits (GMP, GMPD, ISO 9001, 13485, 14001, 21CFR part 11, EXIPACT, Regulation 2017/745).
- Supplier audits (boiler making, computerized systems, automation, transporters and logistics platforms, excipient manufacturers, etc.).
- Data integrity assessment.
- Supply chain assessment.
- Quality management assessment.
Trainings
- ICH Q9, ICH Q10, GAMP 5, GMP, GDP.
- ISO 9001, ISO 13485, 21 CFR part 820, 21 CFR part 11.
- Data integrity.
- Management of change, management of non-conformities.
- Validation and qualification (equipment, automats and computerized systems).
- Supplier audits, internal audits.
- Training of future trainers and auditors.
- Risk analysis.
Computerized systems
- Audits of software suppliers, integrators for the pharmaceutical industry and medical devices.
- Quality Manager IT (management of the IT team, periodic reviews, management of validations and approvals of validation documents).
- Support to the validation of systems (definition of the strategy, verification of validation documents).
- Support for SI risk analysis and data integrity workshop.
Operational quality
- Deviations, complaints, CAPA.
- Tasks forces for crisis issues.
- Optimization of process flows.
Project Management
- Risk analysis.
- GPEC (forecast management of jobs and skills).
Team Management
- Team manager of IT technicians and hospital administration.
- Selection, support, evaluation and activity reviews.
Diplôme(s) – Qualification – Certification
Professional degree – Management of companies through Quality.
Crucial conversations training.
CVO Auditor training and certification.
Trainer training.
Expérience
38 years of experience in Quality systems, Operational quality, IT systems, Supply chain, Process management, Continuous improvement, Lean Six Sigma, Risk management, Audits, Training, Complaints, Deviations, Investigations, CAPA, Customer relations, Projects, Human resources management, Production and Business management.
Business Environment
Pharmaceutical – Biotechnologies – Medical Devices – Cosmetics – Electrical Industry – Wood industry – Business Management in book environment.