Julien R.

Quality Auditing | Operations | Pharmaceutical

France
French, English

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 - Present
Repositioning Drugs for a Better Outcome.

Founder

J.Roche Consulting
2 years
Current position
Sep 2020 - Present
Advising healthcare compagny on Formulation, Development, Industrialisation, Compliance and Commercial strategy

R&D Director Fareva Tech Transfer & Sterile product

FAREVA
2 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 Livron
1 year
Jan 2007 - May 2008
European leader in industrial pharmaceutical processing

Quality Compliance Manager

Haupt Pharma Livron
6 months
Jul 2006 - Jan 2007
European leader in industrial pharmaceutical processing

PharmD, Validation and change control manager

Haupt Pharma Livron
2 years
Oct 2004 - Jul 2006
European leader in industrial pharmaceutical processing

Production Enginering Trainee

Solvay Pharmaceuticals
9 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