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Johnson & Johnson Carrières

Manufacturing Manager (GTO) –EMEA H/F

Eure, France
R&D


Description du poste

Requisition ID: 1805668830W

Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.


Mission : To manage and provide oversight to a series of projects associated with currently marketed OTC finished dose products within the manufacturing environment;


Work Assignements :


1. ENSURE HIGH PRODUCT QUALITY

  • Evaluate the potential impact of proposed changes on quality and efficacy
  • Support the change control process when applicable
  • Participate where necessary in QA-led investigations of process deviations and customer complaints. Support manufacturing trouble shooting activity and propose CAPA where applicable
  • Evaluate manufacturing instructions, specifications and amendment to each.
  • Ensure that current pharmacopeial requirements are met where applicable
  • Perform and support raw material evaluation and qualification
  • Investigate process improvements and oversee the process validation, ensuring adequate documentation is available to support successful registration of projects
  • Support request for information requests which may arise on regulatory variation submission
  • Support request for information requests which may arise on regulatory variation submission
  • Update JnJ Specification systems such as Tru, CONNECT, etc.
  • Manage the technical sections of Authorised Product Release compilation

2. CONTRIBUTE PRODUCT AND PROCESS ENGINEERING EXPERTISE

  • Create pharmaceutical reports.
  • Participate in various cross-disciplinary groups in an expert capacity.
  • Support local manufacturing plant in an expert capacity


3. TRANSFER OF PRODUCTS

  • Actively participate in the Tech Transfer Team
  • Contribute expertise on product and process engineering.
  • Support Process and Analytical optimization, development and validation as required
  • Ensure transfer compliance with current J&J procedures

 

4. REFORMULATION of PRODUCTS

  • Develop product development strategies for current products on market
  • Contribute Expertise on product and process development
  • Actively participate in establishing and developing the process on a production scale
  • Create and/or Review upscaling reports
  • Ensure that adequate documentation is available to support successful registration of products

 

5. PRODUCT and PROCESS IMPROVEMENTS with regards to product quality and cost efficiency

  • Identify and propose :
    • product and process improvements
    • cost improvement and business continuity plans

  • Support commercialization of secondary market launches of new product introductions
  • Ensure that adequate documentation is available to support successful registration of projects

 

6. Management of Third Parties

  • Actively participate in the selection, due diligence and evaluation of Third Party partners
  • Management of technical relationship with Third Party and provide technical supervision to assure that J&J products are produced according to J&J and International standards

 

FURTHER DEVELOP KNOWLEDGE AND SKILLS

  • Maintain necessary good manufacturing practice (GMP) skills through training, technical review and SOPs
  • Have a close collaboration with the Supply Chain
  • Continuously update new research findings and techniques
  • Be responsible for personal development (active participation in planning and employee reviews as well as creation and implementation of personal development plans)

Key Internal Stakeholders;

  • Supply Chain – Manufacturing Sites (Internal and External)
  • Regulatory Affairs
  • Quality Assurance
  • Project Management
  • Sourcing


Qualifications

Educational Requirements:


Educational – Minimum of Bachelors degree with a major in chemistry, chemical engineering or pharmaceutics or equivalent degree.


Work Experience:

  • A minimum of 7-8 years in a pharmaceutical manufacturing or product development environment with a major emphasis on multi-ingredient finished dose formulations.
  • Experience with non-prescription ingredients used in cough, cold & allergy preparations and analgesics is a distinct advantage.
  • Comprehensive understanding of quality compliance knowledge within EU and good understanding of GxP systems
  • A demonstrated business partner and ability to bring together multi-disciplined technical staff in order to problem-solve.
  • Technical writing and documentation review abilities
  • Project management, communication and prioritization skills.
  • Demonstrable experience of working with external manufacturers

Emplacement principal
France-Haute-Normandie-Eure-
Organisation
Johnson & Johnson Santé Beauté France SAS (7101)
Fonction
R&D
Requisition ID
1805668830W