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Manufacturing Science Specialist

Experis | Hainaut | Durée indéterminée, Temps plein

En ligne depuis 14 jours sur Jobat.be

Manufacturing Science Specialist

The Manufacturing Science Specialist II handles large and complex investigations related to manufacturing processes and ensures that adequate corrective actions are implemented in a timely manner.
He defends such investigations in front of regulators. He also works on process improvements and process robustness initiatives and leads such projects from start to implementation, including the submission preparation. He leads risk analyses for existing manufacturing processes as well as for new/upgraded processes. He leads cross-functional groups (also with other facilities), evaluates possible actions to mitigate/reduce the effect of the identified risks, and ensures the follow-up of the implementation of the actions.

Manufacturing Science Specialist

Description de la fonction

Your responsibilities:

Handles complex CAPA investigations related to manufacturing operations. Uses Six Sigma and DMAIC methods where appropriate. In view of this:

  • Defines tasks/experiments to be performed, provides required documentation and ensures also that adequate corrective actions are implemented to address the identified root-cause(s);
  • Ensures and defends adequate deployment, implementation and utilization of all quality systems as defined;
  • Ensures a thorough and timely handling of associated tasks and activities;
  • Ensures and defends the Compliance to cGMP's, GDP's;
  • Procedures by defining, implementing and maintaining appropriate SOP's and training;
  • Favors communication, critical thinking, problem solving and team work across all manufacturing facilities;
  • Defends investigations in front of regulators during audits;

Develops and leads projects that will improve yields, throughput & process efficiency, production process control and/or will reduce process variations. In view of this:

  • Uses QbD, DIDOV, Lean and implements new technologies (including PAT) where appropriate;
  • Conducts risk analyses for existing bulk manufacturing processes as well as for new/upgraded processes (Capacity increase, Change Request, …), evaluate and implement actions to mitigate/reduce the identified risks;
  • Defines tasks/experiments to be performed, provides required documentation and leads the project from start to the implementation, including the submission preparation;
  • Ensures and defends adequate deployment, implementation and utilization of all quality systems as defined;
  • Ensures a thorough and timely handling of associated tasks and activities;
  • Ensures and defends the Compliance to cGMP's, GDP's;
  • Procedures by defining, implementing and maintaining appropriate SOP's and training;
  • Favors communication, critical thinking, problem solving and team work across all manufacturing facilities;
  • Defends submissions in the role of recognized process expert.

As a recognized process expert:

  • Is involved in technology transfers, CMO related activities;
  • Ensures training of personnel on Scientific & Technical topics.

Profil

Your profile:

  • Master or PhD degree in Pharmaceutical Sciences, Bio-Engineering or BioChemistry or equivalent by experience;
  • 3 to 5 years in Pharmaceuticals & Bio-therapeutics manufacturing, in a similar function;
  • Honest and responsible, flexible, customer focused, team player, open minded
  • Critical thinking and Problem Solving;
  • GMP and bioprocessing knowledge and experience;
  • Experience with Technical writing (in English) in preparation of regulatory submission files and defending topics during an FDA or cGMP audit;
  • QbD, DIDOV, Lean, Six Sigma and DMAIC methods as appropriate.

Offre

Interested ? Contact or 02 389 11 76.

Plus d'info

Experis Belgium
Diane LOUPPE

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    Caractéristiques

    Exigences

    • Master (Licence, Université ou Enseignement Supérieur de Type Long)
    • Français

    Offre

    • Durée indéterminée
    • Temps plein

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