About the job

Main purpose of the job

  • Assist in developing, maintaining and updating the Animalcare Quality Management System for medicines, medical devices, feed supplements and skin care products to comply with current regulations.

  • To coordinate quality assurance activities relating to Animalcare licensed veterinary medicinal products.

Key Responsibilities and Accountabilities Responsibilities as Quality Associate:

    • Support in the development, maintenance and update of the corporate QMS;
    • Audit: execute and follow-up of internal and external audits;
    • Initiation and/or assessment of deviations and complaints;
    • Initiation, assessment and management of change controls and CAPA plans;
    • Plan, collaborate and check qualifications and validations;
    • Writing management, quality related or technical reports;
    • Perform and keep overview of quality-related tasks e.g. (mock)-recall, return goods/counterfeit product management, follow up of manufacturing activities, stability studies and Product Quality Reviews (PQRs), etc.;
    • Supervise the correct completion of work documents;
    • To keep up to date the qualification/approval status of Ecuphar suppliers;
    • To keep up to date the Ecuphar customers qualification for the proper distribution according the law;
    • Plan, coordinate, perform and keep overview of the training of (new) employees;
    • Transfer to sellable stock of product received from suppliers against respective Certificates of Analysis and approved packaging;
    • To prepare and manage QTA's (e.g. suppliers, distributors, warehouses, etc.);
    • To attend audits performed by third parties or Health Authorities;
    • To assure a Quality oversight of manufacturing, storage and transport activities;
    • Perform work in accordance with regulation and permits;
    • Support in budget control of expenses;
    • Support in various operational issues customer service and supply chain;

Key Qualifications & Experience Have a good understanding of regulatory and GxP requirements; 

Propagate and defend the quality policy within the organisation.

  • Good Technical Skills;

  • A logical and investigative mind;

  • A methodical approach to work;

  • Availability to travel for Audit purposes;

  • Teamworking skills;

  • Interpersonal skills;

  • Writing and communication skills;

  • ICT skills;

  • Quality and customer orientated

Required experience Minimum of 2 years pharmaceutical industry experience in area of Quality, Regulatory and operational GMP and/or GDP.

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