- 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.
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
- Interpersonal skills
- Writing and communication 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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