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Sr./Quality Engineer

  • Job type: Permanent
  • Location: Boston
  • Salary: $80000 - $120000 per annum
  • Job reference: KYRH 629
  • Sector: Quality Assurance, EPM Scientific, Quality
  • Date posted: 29/06/2017
Sr./Quality Engineer

A large, global pharmaceutical + Medical Device company with a strong pipeline of products is currently seeking a Senior/Quality Engineer to join their team! This company has been globally recognized for its success and is looking to continue to expand. They focus on both generic and branded pharmaceuticals and are responsible for developing, manufacturing, and marketing their products. This company covers a large pool of therapeutic areas and has a proven track record!

The Sr./Quality Engineer will have the following responsibilities:   

The selected individual will come primarily from a GMP background and the ability to provide overall QA approval of Quality documentations. They will have validation experience and be able to develop validation programs. The Senior Quality Engineer will also be a liaison between the R&D and Manufacturing teams. They will have the capability to mentor junior staff within the QA team.
  • Develop Validation Programs
  • Support New Product Development 
  • Work with R&D as well as Manufacturing teams
  • Risk Assesment of validation plans
  • Design control

The ideal candidate will have the following skill set:
  • Minimum 5 years experience within GMP Quality
  • Bachelor's Degree in related discipline
  • Strong knowledge of FDA requirements and ICH guidelines
  • Strong communication skills
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