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Quality Assurance Engineer - France  

Nalys (company)


Posted on : 16 April 2017

Project Description

  •  Thanks to our strong corporate values and  management, we are one of the fastest growing actors in engineering consultancy.
  •  We gather great minds & challenge boundaries to help our customers develop stunning products. And we love doing it.

About the job
 You will be part of a global project whose objective is focusing on development and production of treatments for severe diseases, particularly in the field of central nervous system, inflammatory disorders and oncology. Working for the Global Quality Assurance Department, you will join a team of experts dedicated to maintaining a high level and harmonization in QA processes. 

As QA expert, you will ensure that each medicine reaching a patient is safe, effective and of good quality and to have quality operations that support those objectives.

Your next challenge will include the following responsibilities:  
  • You will lead, design & manage quality programs, policies, processes, procedures and controls. You will deal with the Quality policy & objectives and document those.
  • You will write & update SOP’s, training materials & other cGMP related documents and you will manage documentation in conformance with SOP’s.
  • You will perform GMP compliance operations including batch record review, evaluation of incident reports & follow up with all respondents, shop floor in conformance with SOP’s.
  • You will design protocols, analyse data’s & perform audits and inspections to check conformance.
  • You will participate to investigation of deviations in a cross-functional team environment and you will approve them.
  • You will seek resolutions and answer customer complaints. & bring CAPA solutions coming from deviations, complaints, audits & ensure its correct implementation & follow up.
  • You will analyse, review and approve change controls & create or review Product Quality Review.
  • You will create and review Quality Agreement to manage CMO.
  • You will be QA responsible for product technical transfer.
  • You will analyse and improve all quality systems. & facilitate cross team meetings to find solutions.
  • You will ensure that the performance & operations/products quality conforms to standards.  

About you 
  • You hold a Master degree in Pharmaceutical or related studies
  • You hold at least 3 years’ experience as QA
  • You are fluent in English and French.
  • Corporate values mean a lot for us. We expect them to mean something for you  

About us 
  • We will give you the opportunity to challenge yourself while doing something you love.
  •  So whether you are a creative, a dreamer or an achiever, you can find a way to do something you truly enjoy.
  •  And because we want our company values to be more than words, we invest 7% of our annual revenue to drive innovation, develop your expertise, train your brains and give you time & tools to think big.