Manufacturing Manager (GTO) – EMEA F/M

Johnson & Johnson

Manufacturing Manager (GTO) – EMEA F/M

Johnson & Johnson Sante Beaute France

Eure, France

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 the 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 the 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.

Primary Location
France-Haute-Normandie-Eure-
Organization
Johnson & Johnson Santé Beauté France SAS (7101)
Job Function
R&D
Requisition ID
1805668830W

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© EuroJobsites 2018

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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