QA Operations _ Drug Substance Manufacturing

☞ Manpower

Ver: 138

Dia de atualização: 26-03-2024

Localização: Yverdon-les-Bains Vaud VD

Categoria: Farmacêutico / Químico / Biotecnologia

Indústria: Ressources humaines et recrutement

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Conteúdo do emprego

Your assignment

For this role you will be responsible for the Quality oversight of the manufacturing operations of monoclonal antibody.

The role will cover Upstream and Downstream manufacturing and solutions preparation.
You will ensure a strong collaboration with other Bioplant functions and will promote compliance and continuous improvement while supporting the on-time supply of products.


More specificly, you’ll have to :

  • Manage the day-to day quality oversight of the USP and DSP manufacturing and solutions preparation
  • Review manufacturing SOPs to ensure compliance with Incyte Policies and regulatory requirements
  • Ensure compliance of manufacturing activities with cGMPs and approved procedures
  • Perform Batch Record Reviews within defined timelines
  • Manage & Approve deviations, investigations and CAPA plans
  • Review, assess and approve implementation of changes
  • Represent QA function in manufacturing routine operational meetings
  • Foster compliant and right first time operations Foster the understanding and the application of Good Manufacturing Practices (cGMPs) by bioplant employees
  • Operate in close proximity with manufacturing in order to foster prevention and anticipation of potential issues as well as the timely handling of unexpected events
  • Interpret GMP, general regulatory requirements and Quality systems regulations in the area of manufacturing and ensure implementation as applicable,
  • Performs all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements

Your profile

  • Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering);
  • First hand experience in Quality Operations for pharmaceuticals at manufacturing sites;
  • Thorough knowledge in cGMP and international regulatory requirements;
  • Expertise in Biotechnology products
  • Strong analytical and problem solving skills;
  • Good verbal and written communication skills with well-structured communication;
  • Fluent in French written and spoken (the company language) and ideally good level in English

Interested?

We’re looking forward to receive your applications !

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Data limite: 10-05-2024

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