Julien R.
Quality Auditing | Operations | Pharmaceutical
18+ years in the Pharmaceutical Industry, with 12+ years of experience in quality assurance
- Biotech, Pharma & Life Sciences
- Biotech, Pharma & Life Sciences
€400
/hr
- Pre-vetted expert
- Confirmed hourly rate
- Available on short notice
Experience
Senior Director European Operations
Nevakar Inc.2 years
Current position
Nov 2020 - PresentRepositioning Drugs for a Better Outcome.
Founder
J.Roche Consulting2 years
Current position
Sep 2020 - PresentAdvising healthcare compagny on Formulation, Development, Industrialisation, Compliance and Commercial strategy
R&D Director Fareva Tech Transfer & Sterile product
FAREVA2 years
Sep 2018 - Nov 2020
- In charge of Global Tech Transfer Process definition and implementation - Work throughout all Fareva Pharma plant worldwide - Strong customer orientation and problem solving mindset
Pharmaceutical Development Manager - EXCELVISION -
EXCELVISION (Groupe FAREVA)9 months
Nov 2017 - Aug 2018
- New product introduction - Filling support for Drugs and Medical device (EMEA, US, KFDA, Russia,...) - First Technical/Commercial contact for all new customer or new product
Head of QA
EXCELVISION (Groupe FAREVA)5 years
Aug 2013 - Sep 2018
- Quality System management (CAPA, Change control, Deviation, Operationnal QA in production,...) - Audit/Inspection Management (customer and health authorities) - Rx and Medical Device ...see more
Head of Quality Compliance
EXCELVISION (Groupe FAREVA)1 year
May 2012 - Aug 2013
- FDA Agreement - Design of compliant and efficient Quality System to match Customer /Authorities expectations and CMO needs
Head of system QA
Excelvision (Fareva Holding)4 years
May 2008 - Oct 2012
Since the company was founded in 1990, our objective at Fareva has always been to offer customers impeccable service by providing tailored R&D, production and packaging facilities which...see more
Head of Quality Assurance / Qualify Person
Haupt Pharma Livron1 year
Jan 2007 - May 2008
European leader in industrial pharmaceutical processing
Quality Compliance Manager
Haupt Pharma Livron6 months
Jul 2006 - Jan 2007
European leader in industrial pharmaceutical processing
PharmD, Validation and change control manager
Haupt Pharma Livron2 years
Oct 2004 - Jul 2006
European leader in industrial pharmaceutical processing
Production Enginering Trainee
Solvay Pharmaceuticals9 months
Jan 2004 - Oct 2004
Solvay is a Belgian multinational company active in chemicals and plastics.
Industries, roles and expertise
Industry experience
- Biotech, Pharma & Life Sciences
- Biotech, Pharma & Life Sciences
Expertise
- Quality Assurance
- Quality Auditing
- Quality System
- GMP
- Validation
- GLP
- CAPA
- FDA
- Change Control
- Technology Transfer
- Computer System Validation
- FDA GMP
- Aseptic Processing
- Cleaning Validation
- Contract Manufacturing
- GxP
- Sterilization