Stage - Chemical Compliance Engineer Assistant (H/F)

Stage
Lestrem
Salaire : Non spécifié
Télétravail fréquent
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Roquette
Roquette

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Le poste

Descriptif du poste

As a long-established global provider of plant-based excipients and life-saving active ingredients for the pharmaceutical and biopharmaceutical industries, Roquette offers a competitive broad-range of customer-focused solutions. The safety of your patients is your first objective. That's why the quality and the compliance of our product is our challenge.

In this context, we have to perform tests according to analytical practices and methods describes in the International Pharmacopeia.

You want to discover the activity related to validation/comparison in the field of the manufacture of active ingredients, and its related activities, in an industrial environment oriented towards the pharmaceutical sector? This job is for you!

Job description:

You will be required to work for a period of 6 months in the Global Operational Quality Department - Global Quality Control sector under the responsibility of the Global QC specialist for validation.

The role of "Global Quality Control" is to:

  • To provide support and expertise to the local Quality Control functions of the different sites of the Roquette Group.
  • Define, develop and manage the Quality Control group standards
  • Participate in the development of skills in all the Group's laboratories
  • Evaluate or even implement new solutions or technical tools or methods to improve reliability, laboratory performance, and compliance with standards and meet customer needs.

You will work with the Global teams and the local Quality Control teams based in Lestrem, Northern France.

You will be responsible for the following varied activities:

  • Identify methods dealing with same criterion
  • Participate in the drafting of comparison protocols according to the Group procedure.
  • Carry out analyses to compile comparison files (these comparison activities must meet the requirements of GxP guidelines).
  • Participate in the writing of comparison reports according to the Group procedure.
  • Write draft of a single method per criteria responding referential requirements
  • Support changing with AQ and QC lab Teams

From a chemistry engineering school or a Master 1 or 2 in Chemistry with a pharmaceutical option or equivalent.

Gifted with a real capacity for practical and synthetic thinking, rigour, autonomy and editorial quality,

At ease with relationships, you have a taste for practical laboratory work and wish to evolve within an industrial environment that encourages initiative and teamwork.

You have a good command of English (minimum level B1), computer tools / office pack and possibly other digital tools (Teams, ...).               

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