Senior Quality Engineer

You put your knowledge of GMP manufacturing and engineering into practise by contributing to the quality management system to get this 'audit-ready'. For this purpose you validate processes, documentation and deal with CAPA's in a GMP environment

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What will your job be

As Senior Quality Engineer you work closely with professionals throughout the organisation, covering all actions required to improve the quality managament systems in a GMP manufacturing environment.

  • You ensure GMP compliance of the quality management sytem (QMS) and make sure that systems and processes that are aligned with the company's strategy and regulatory requirements mission effecting continuous quality improvement
  • In your role as senior Quality Engineer you support, consult and lead quality improvement projects throughout the life cycle of the products. This includes product design and development, manufacturing, purchasing and improvements
  • For this purpose you review validation documentation, software validation and investigations. You identify gaps and solve these
  • Moreover, you conduct/lead CAPA's and use statistical tools to analyze process/product/QMS data and to identify improvement opportunities
  • This way, you ensure that operations are done in compliance with the guidelines of regulatory authorities (e.g. FDA) and help to make the QMS and operations audit ready

What are we looking for

For the position of Senior Quality Engineer we are looking for an enthusiastic candidate with a relevant educational background who meets the following qualifications:

  • An academic (MSc, PhD) degree in engineering or science. Experienced BSc-level candidates are also considered
  • At least 5 years relevant experience of which 3+ years with pharmaceutical or medical device companies
  • Knowledge of statistics, software and process validations, combined with (basic) knwoledge of computer systems
  • You thrive when doing multidisciplinary work, solving complex issues and have strong communication and influencing skills
  • Fluent in English. Dutch is considered a plus

What do we offer

  • Secondment via CheckMark Labrecruitment for 10 months
  • Fulltime position

Where will you work

This company develops and manufactures pharmaceutical products

More information

Coen Smiers
0182 590 218
Na Rae de Jong
0182 590 216
Ref.nr: 5447

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