QA Officer
at EcupharMain purpose of the job
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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.
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To coordinate quality assurance activities relating to Animalcare licensed veterinary medicinal products.
Key Responsibilities and Accountabilities Responsibilities as Quality Associate:
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- Support in the development, maintenance and update of the corporate QMS;
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- Audit: execute and follow-up of internal and external audits;
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- Initiation and/or assessment of deviations and complaints;
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- Initiation, assessment and management of change controls and CAPA plans;
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- Plan, collaborate and check qualifications and validations;
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- Writing management, quality related or technical reports;
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- 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.;
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- Supervise the correct completion of work documents;
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- To keep up to date the qualification/approval status of Ecuphar suppliers;
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- To keep up to date the Ecuphar customers qualification for the proper distribution according the law;
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- Plan, coordinate, perform and keep overview of the training of (new) employees;
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- Transfer to sellable stock of product received from suppliers against respective Certificates of Analysis and approved packaging;
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- To prepare and manage QTA's (e.g. suppliers, distributors, warehouses, etc.);
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- To attend audits performed by third parties or Health Authorities;
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- To assure a Quality oversight of manufacturing, storage and transport activities;
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- Perform work in accordance with regulation and permits;
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- Support in budget control of expenses;
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- 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.
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Good Technical Skills;
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A logical and investigative mind;
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A methodical approach to work;
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Availability to travel for Audit purposes;
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Teamworking skills;
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Interpersonal skills;
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Writing and communication skills;
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ICT skills;
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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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