An opportunity has arisen for a QA Officer to join the Quality Assurance team. The role will assist in the implementation and maintenance of GxP cross-company QA processes.
The key responsibilities will be to:
- Assist in updating and maintaining WDA(H) documentation.
- Provide support in creating and updating GDP and Quality related processes and documentation.
- Coordinate supplier related Quality Incidents and participate in Supplier meetings.
- Coordinate deviation reports and/or CAPAs.
- Provide refresher training and induction training in GxP disciplines.
- Prepare data for operational and quality meetings.
- Contribute to the continuous improvement of quality processes.
- To assist in the quality management of suppliers including performing audits, where required.
Key Attributes/Skills:
- Relevant quality experience in a Pharmaceutical or Medical Device environment along with a degree (or equivalent) in a relevant scientific discipline.
- Clear understanding of; GMP, or any other GxP area, regulatory and accreditation systems, and quality management.
- Excellent interpersonal skills to be able to liaise effectively with a variety of internal audiences.
- Ability to analyse information and prepare coherent investigative/technical reports.
- Excellent attention to detail.
- Competence in computer packages, Microsoft Office, and electronic quality management package (preferred) and advanced excel skills to be able to create pivot tables, design databases and dashboards.
- Ability to plan, organise and priorities tasks to achieve deadlines.
- Emotionally resilient with the ability to work under pressure in a continually changing environment.