QA Officer

Ecuphar; York and North Yorkshire; On-site; GBP 42,000 - 56,000; Full time

Job summary

Ecuphar is seeking a Quality Associate to support the Animalcare QMS across medicines, devices, feed supplements and skin care products to ensure regulatory compliance.

You will coordinate QA activities for Animalcare licensed veterinary medicinal products, perform audits, manage deviations and CAPA, and oversee change controls, qualifications, validations, and supplier/customer qualification processes.

Qualifications

• Minimum of 2 years pharmaceutical industry experience in Quality, Regulatory and operational GMP and/or GDP.
• Have a good understanding of regulatory and GxP requirements.
• Propagate and defend the quality policy within the organisation.

Responsibilities

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

Skills

Good technical skills

Logical mind

Methodical approach

Travel availability

Interpersonal skills

Writing & communication

Quality & customer orientation

Job description

• 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.