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R&D / NPD

Formulation, analytical development, packaging
Design, raw materials and supplier evaluations
R&D Laboratory testing
R&D documents (Medical device : DHF, Risk Analysis, V&V reports – Pharma: protocols and tests reports, change control)

Industrialization

V-Model
Industrial transpostion
Scale up, scale down
Users Requirements Specifications
New production zone building projects or transfer between two sites
Audit and management of suppliers
Development and installation of equipments, production ranges and control ranges

Qualification / Validation

FAT/SAT/IQ/OQ/PQ
QV documentation: VMP, protocols, reports
Commisioning and test capitalization
Equipment qualification (automated or not)
Process validation (cleaning, conditionning, sterilization)
Computerized systems validation
Data integrity

Process engineering

Medical Device : assembly, machining, cutting, polishing…
Pharma: dry, liquid, sterile, injectable forms…
Cleaning, serilization, conditionning
Technical investigations
Bespoke equipment installation
Process optimization
Process validation

System QA

Audit preparation, and follow-up and inspection (internal, external and supplier audit)
QMS implementation and maintenance
ISO 13485, GMP, 21 CFR part 820
Risk analysis

Operational QA

Quality event management: NC, deviations, CAPA, change control
Steps coordination: reminder, opening, approbation…
Technical investigations: 5M, 5 Why
Field investigation
Tracking of quality KPIs

Production

Continuous improvement
Deviations management
Equipment optimization
Introduction of new products into production
Planning and production support
Staff training

Quality control

Analytical methods validation
OOS and OOT management
Chemistry, biology, mechanic, microbiology laboratory
Data integrity
Analytical methods optimization

Regulatory affairs

CE marking
Export
MDR transition
New international markets
Risk 14971
Pharmaceutical
Product registration
market approbation
eCTD writing / updating (1 to 5)
Pharmacovigilance and material vigilance
Files redaction
Manage relationships with health authorities

Project management

Hazard management (human, projects, etc…)
Leading technical and decisive meetings
Triple function: technical, operational, decisional
Projects examples: quality remediation, building of new production spaces, equipment purchase, product development…