GMP Expert

Posted 8 months ago

GMP Expert

Halton, Lancaster

£30,000 – £35,000 (possibly flexible depending on experience)


Our client is a leading provider of cleanrooms and contamination control products to a wide range of high-end manufacturing and healthcare sectors in the UK and internationally.

We are seeking an ambitious and highly motivated GMP Expert to join their team, as the company’s in-house GMP specialist. The GMP Expert will operate across all revenue streams taking cleanrooms, consumables, training and testing into account as well as collaborating externally with our customers. This exciting new role will work across all departments and be a pivotal role in developing and influencing the company’s growth and direction.

The role

The role will include the following responsibilities:

  • Develop short and long-term strategies to further advance the organisation’s success and continued growth in the GMP segment over the next 5 years
  • Appraise the current product portfolio in regard to GMP cleanrooms and consumables, finding and onboarding the product improvements, alternative options and new offerings to service the GMP segment
  • To be the company expert in all aspects relevant to GMP, including but not limited to; other forms of relevant guidance e.g. ISPE, PIC/S, IEST guidelines, FDA literature
  • Take a lead role in delivering GMP training to various disciplines within the organisation
  • Develop GMP training which can be offered as a service to clients
  • Manage GMP projects which will involve supporting the sales and estimations process, leading the handover process from sales to operations, and then leading the cleanroom programme delivery with the operations team
  • Design DQ, IQ and OQ documentation and execute DQ, IQ OQ for all GMP projects
  • The role reports to the Head of Business Development; you will work closely with the sales, estimating and operations teams.
  • The role will involve some travel to customer sites and there is an expectation to support Regional and European offices remotely

Required experience

  • Extensive knowledge of cGMP and ISPE guidance
  • Significant understanding of GMP environments, processes and practices
  • Experience of designing DQ, IQ & OQ documentation
  • Experience of developing and implementing strategies
  • History of achievement in an engineering or other relevant team
  • Experience of preparing and reviewing terms and conditions and contractual obligations
  • Sales and negotiation skills
  • Commercial awareness
  • Knowledge of engineering principles
  • Full, clean driving license

Desirable experience

  • Cleanroom technology certificate
  • GMP training relevant to the role
  • Experience of working within an SME
  • Experience in managing technical challenges collaboratively in a successful sales, design & engineering team
  • Experience in developing and delivering training
  • Sage systems (50 or 200)
  • CRM systems
  • B2B
  • Foreign languages
  • Highly skilled in managing complex project design and functional solutions
  • Solutions focused

The package

 Along with a competitive salary for the right person, the business also offers:

 Full induction and orientation

  • Training and development
  • Company Contributory Pension Scheme
  • Health Care Scheme
  • Mentoring & coaching specialist programmes
  • Team building activities
  • Awards
  • Corporate social responsibility schemes

This is a great opportunity for someone to join a fantastic company with an amazing working environment, and to join a team who are all proud of what they do.

If you are interested in this position and feel that you have the required knowledge and experience, then please apply with your latest CV and you will be contacted with more information.


Job Features

Job CategoryBuilding Services, Business Development, Engineering, M&E Services, Manufacturing, Project Management

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