Quality Assurance Analist
SIRE
Antwerpen, Belgium
9 dagen geleden

The company

Our client is a professional Pharmaceutical organization, based in Antwerpen Belgium. The passion of the company is to improve the lives of all their patients.

They are an healthy and growing organization who is focused to develop new treatments.

Role description

This is an overarching role where you, as QA Analyst, are responsible for the quality assessment and evaluation of locally produced medicines based on the results of the inspections performed and the review and evaluation of the batch documentation.

You will work closely with the Production department and support departments and helps to design, continuously improve and follow up control systems, as well as train colleagues and share knowledge within the teams.

This function supports the QO Engineer in handling quality deviations and manages the planning to release batches.

Responsibilities

As QA Analyst you take care of the continuous improvement and control of the quality processes within the team : for example by writing and adjusting QA-

related procedures, reporting atypical incidents that you have established, charting points for improvement in the batch documentation process and other specific assignments.

The following tasks fall under your authority :

  • Performing the review of the batch documentation of aseptic bulk and semi-finished products and underlying processes.
  • The input of test results in LIMS.
  • The QA release of water and bulk locks and underlying processes.
  • Follow-up, planning and preparation of batch-related documentation to batch release.
  • The preparation of batch-specific certificates.
  • The administrative and technical support in, among other things, dealing with deviations in gQTS, together with the QO Engineer.
  • Requirements

  • Bachelor or master degree in a life sciences field
  • 3 years of experience within a quality or production environment
  • Quality minded and knowledge of cGMP
  • Fluent in English and Dutch
  • Able to work with computer programs like LIMS and SAP (or at least able to learn this in a small amount of time)
  • Strong team player who is also able work alone
  • Solliciteren
    Bij de favorieten invoegen
    Verwijder van favorieten
    Solliciteren
    Mijn E-mail
    Door op "voortzetten" te klikken, gaat u ermee akkoord dat neuvoo uw persoonlijke gegevens verzamelt en verwerkt die u in dit formulier hebt verstrekt, om een ​​neuvoo-account te maken en u te abonneren op onze e-mailwaarschuwingen, in overeenstemming met ons Privacybeleid . U kunt uw toestemming te allen tijde intrekken door te volgen deze stappen .
    voortzetten
    Aanvraagformulier