QA Officer

An opportunity has arisen for a QA Officer to join the Quality Assurance team. The role will be responsible for the development, improvement, and maintenance of the Quality Management System (QMS).

The role will include but not be limited to the following:

• System administrator of eQMS (DOT Compliance computer system).
• QA representative for ERP, IT and CSV department QMS activities.
• Co-ordinating, monitoring and preparing KPI reports on the Diomed QMS.
• Act as administrator & primary contact for the eQMS processes.
• Act as trainer for the eQMS processes and QA Induction for staff at Gosmore (Change Controls, Deviations & Quality Events)
• Supplier Performance reviews – computer systems
• Performing internal audits across GxP areas
• Perform QA review of DQA procedures/work instructions.
• Management of Gosmore QA Training Matrix.
• Maintenance of Adobe Risk Register and user list.
• Signix administrator and trainer.
• Act as back-up for administration and management of the Audit programme and Technical Agreements.
• Contributing to continuous improvement of QMS in line with overall improvement and harmonisation of the Diomed Group QMS as requested by QA Manager.
• Responsible for organising and involvement in Competent and Notified Body audits and inspections.

Key Attributes/Skills:

• Quality experience in a pharmaceutical environment along with a degree (or equivalent) in a relevant scientific discipline is desirable.
• Clear understanding of GMP or any other GxP area, regulatory and accreditation systems, and quality management.
• Experience/knowledge of pharmaceutical computer systems
• Excellent analytical thinking to evaluate information and understand complicated issues.
• Excellent interpersonal skills to be able to liaise effectively at different levels of the business.
• Ability to analyse information and prepare coherent investigative/technical reports.
• Competence in computer packages including Microsoft Office and electronic quality management packages.
• Competence in preparing presentations, delivering training to a variety of internal audiences.
• Ability to plan, organise and manage multiple projects.
• Emotional resilience with the ability to work under pressure with a can-do attitude.
• Excellent attention to detail and documentation skills.