QA Officer

Belgium  ‐ Vor Ort
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Beschreibung

RESPONSIBILITIES:
  • Define and maintain a quality management system that is consistent with the requirements. Proactively develop and improve it.
  • Draw up a quality assessment by constantly evaluating the company: its organization, its functioning, the behavior of the personnel, its installations, its equipment, its procedures, and others in relation to the standards in force (GMP, Belgian and possibly foreign legislation , etc.)
  • Carrying out internal and external audits (suppliers, subcontractors) and ensuring that appropriate improvement actions are taken by the various departments concerned.
  • Supervision of the level of quality and compliance with standards and procedures in the various departments. Participate in the reaction of the corresponding procedures.
  • Prepare and participate in audits carried out by customers, authorities, in close collaboration with the departments concerned. Write the reports and corrective and preventive action plans following the report sent by clients / authorities and ensure their dissemination.
  • Follow up on deviations / CAPA. Ensure the investigations and propose an analysis concerning the planned and unplanned deviations.
  • Ensure, in collaboration with the departments concerned, the qualification of equipment and the validation of processes whenever required by GMP, legal provisions or specific production conditions at the plant.
  • Participate in the company's R&D activities:
    • Either by drawing up the specifications of the products to be developed
    • Either by drafting protocols relating to development
    • Either by implementing the protocols
    • Either by compiling and analyzing development results
  • Review of batch records
  • Approval and archiving of master documents
  • Supervise the organization and maintenance of the legal pharmacothèque.


SKILLS REQUIRED FOR THE FUNCTION:
  • Training:
    • Technical Master, Bio Engineer or equivalent experience
  • Experience:
    • Knowledge of GMP rules (cross contamination, product quality, risks linked to their defects,…), GLP and GDP.
    • Knowledge of MS Office tools.
    • Fluency in French and English.
    • 3 years of experience in a similar function


CANDIDATE PROFILE:
  • Depending on their level of knowledge and know-how, helps achieve their goals by performing tasks listed in other job descriptions
  • Relay information in a positive and constructive way
  • Knowing how to work in a team, while being autonomous
  • Ability to react to abnormal situations
  • Rigor and "intellectual honesty".
  • Sense of responsibility.
  • Knowing how to prioritize the different tasks.


Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Start
12/2020
Dauer
6 months
Von
Michael Bailey Associates
Eingestellt
28.10.2020
Projekt-ID:
1989886
Vertragsart
Freiberuflich
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