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QA Ops

EXPERIS | Wavre | Durée indéterminée, Temps plein

En ligne depuis 9 jours sur Jobat.be

QA Ops

Description de la fonction

Purpose of the Mission

The QA Primary Operations projects is part of the QA Organization for one MPU. He/She ensures the QA oversight of the Operational GMP activities for one or several vaccine bulk production units.

Main Responsibilities

  • To take part, through the QA oversight, in the establishment, the implementation and the followup of several projects,
  • To review and approve change controls (CC),
  • To review and approve some validation documentation (VP, VSR, Risk Assessment, Gap Analysis),
  • To review and approve specific manufacturing documents (SOP, BR, eCC),
  • To ensure the correct application of the quality systems on the field and to define improvement plan as required,
  • To support the production & technical services teams in the implementation of the activities, - To ensure the adequate management of change controls (be QA GMP Responsible) and potentials CAPA (be Compliance Authority).
  • Challenge, review and approve GMP documents (eSOP) and GMP processes (Change controls, CAPA) and ensure they are written in accordance with the Vaccines standards and procedures. - Review and approve some validation (VP, PQ, PV, VSR, PVMP) documentation according to the Bio standards and procedures.
  • Ensure adequate oversight and follow-up on the projects and the change controls
  • Support from a compliance point of view the MPU Projects, Product&Process, Production and QA Operations.
  • Build a strong partnership with these key stakeholders
  • Knowledge of GMP Regulated environment related to GMP operational activities
  • Understand quickly the characteristics and the mechanism of a broad range of production equipment and process including their potential impact on product and patient safety.
  • Use a risk based approach for problem solving and prioritization of tasks
  • Blow a quality and compliance mindset through the projects activities
  • Develop and continuous improve expertises linked to the primary GMP activities - expert on the field, technical and regulatory watch over, linked with global and corporate expertise functions

Soft Skills

  • Good interpersonal relationship skills
  • To be a good team player in order to success in each validation or Operational project
  • Problem solving and achievement oriented

Education

  • University degree (Biotechnology, Agronomy, Chemistry or Pharmacy) - At least 5 years professional experience in pharmaceutical environment.

Language

  • French: Good oral and written communication
  • English: Good oral and written communication

Profil

Soft Skills

  • Good interpersonal relationship skills
  • To be a good team player in order to success in each validation or Operational project
  • Problem solving and achievement oriented

Education

  • University degree (Biotechnology, Agronomy, Chemistry or Pharmacy) - At least 5 years professional experience in pharmaceutical environment.

Language

  • French: Good oral and written communication
  • English: Good oral and written communication

Offre

CDI, consultancy

Intéressé(e) ?

Experis Belgium
Catarina Caleja Machado
32 2 639 10 70
Wavre

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Caractéristiques

Exigences

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

Offre

  • Durée indéterminée
  • Temps plein

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