Jobs

Interim Manufacturing Manager - Southern

Medical/Pharmaceutical - Manufacturing
Ref: 252 Date Posted: Monday 29 Oct 2018
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Are you looking to be Interim Manufacturing Manager?

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 GSS, CONNECT, etc.
  • Manage the APR process

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 procedures

 

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

 

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

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

Regulatory Affairs

Quality Assurance

Sourcing

 

Educational Requirements:

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

Work Experience:

  • A minimum of 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

Specialists in consultancy


At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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