Vincent Berny
Quality Director
53 ans
Permis de conduire
Marseille Area France
Situation professionnelle
En poste
Indisponible
Présentation
After a 7 years long experience in the contract manufacturing field and 1 year within the operational quality team of Janssen Cilag's Val de Reuil plant, I took 5 years ago the Pharmaceutical Responsibility of Tournon Fareva Site, manufacturing veterinary products and pharmaceuticals in sprays.
Specialties: Manufacturing & Contract manufacturing of pharmaceuticals products.
Injectables products in ampoules (aseptic filling or terminal sterilisation)
Solid dosage forms (suppositories, hard gelatine capsules, tablets, film coated tablets).
Sprays (liquids and powders).
Packaging.
International Project Management
Specialties: Manufacturing & Contract manufacturing of pharmaceuticals products.
Injectables products in ampoules (aseptic filling or terminal sterilisation)
Solid dosage forms (suppositories, hard gelatine capsules, tablets, film coated tablets).
Sprays (liquids and powders).
Packaging.
International Project Management
Qualified Person, Pharmacist Responsible
Ardepharm - Fareva
Décembre 2009
à septembre 2017
CDI
Tournon sur Rhône
France
- Regulatory Inspections
- International Audits
- Quality Assurance Manager
- SOP and Corporate Guidelines
- Responsible for pharmaceutical activities in a spray manufacturing unit of veterinary products and pharmaceuticals
Pharmacist, Quality & Compliance manager
Janssen-Cilag (Johnson & Johnson)
Septembre 2008
à 2009
- Product Quality Review.
- CAPA determination and follow up.
- Recurrences and tendencies reporting.
- Root causes identification.
- Investigation coordination following events and non conformities.
- Semi-finished and finished products batch release (Delegated Qualified Person).
Head of Customer Service
Haupt Pharma
Mars 2007
à 2008
- .customer relationship on a day-to-day basis
- .corporate reporting
- .site visits and audits
- .complaints monitoring for sales
- .coordination all issues for already existing products
- .handling of ongoing orders, monitoring of delivery performance
- .calculation of new inquiries, offers formulation, pricing
- Management of Customer Service (3 persons):
- Transfer & development activities management (Followed certification process as Project Management Professional (PMP®) by Project Management Institute).
New Products Introduction
Haupt Pharma
Juillet 2004
à mars 2007
- Production and analytical transfer Management, more than 30 projects in steriles, solids and semi-solids dosage forms.
- Customer Relationship Management
Validation Manager
Haupt Pharma
Novembre 2001
à 2004
- Process Validation
- IT system Validation
- Equipment Qualification
Quality Assurance Trainee
Pierre Fabre
Avril 2001
à 2001
- Building of a anomalies management system for the pharmaceutical industry
- Supplier Quotation in SAP
Quality Assurance Trainee
DistriB3
Avril 1999
à février 2000
- Internal Audit questionnaire, lab analysis
English
French
German
Spanish
Process Validation
International Networking
Validation
21 CFR Part 11
Microsoft Office
Water Treatment
Contract Manufacturing
Gmail
International Project Management
GMP
CAPA
Quality Assurance
Medical Devices
Technology Transfer
Change Control
Quality System
Regulatory Requirements
Quality Management
Quality Control
Pharmaceuticals
SOP
Customer Relations
Regulatory Affairs
Quality Auditing
Trackwise
V&V
MS Project
Product Development
Continuous Improvement
Formulation
SAP
Packaging
Outlook
Sterilization
Recipe Testing
Cleaning Validation
Customer Service
Business Networking
FDA
Change Management
GxP
Manufacturing
GLP
Google Docs
LIMS
Pharmaceutical Industry
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