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 systems and processes.
The role will include but not be limited to the following:
- Supporting the configuration, validation, and implementation of computerised systems i.e. eQMS, and Document Management.
- Preparing and delivering QMS training sessions and employee induction training.
- Prepare data for operational and quality meetings.
- Assist in the organising and co-ordinating activities for regulatory inspections.
- Performing administration duties as required for selected quality processes.
- Cross-training with other QA Officer(s) to ensure different QA Workflows can be covered.
- Other QA related tasks as assigned by the company.
- Leading and performing internal audits across a variety of GxP areas.
- Involvement in key quality processes i.e. Deviation/CAPA, Change Control, Audits etc.
Key Attributes/Skills:
- Relevant quality experience in a pharmaceutical sector along with a degree or equivalent experience in a relevant scientific/technical discipline.
- Clear understanding of; GMP, or any other GxP area, regulatory and accreditation systems, and quality management.
- Good understanding of a process approach and competent in process mapping.
- Excellent interpersonal skills to be able to liaise effectively at all levels of the business.
- Demonstrable ability to take decisions, to analyse information in a logical manner and to prepare coherent investigative and/or technical reports.
- Competence in computer packages, Microsoft Office, and electronic quality management system (preferred) and advanced excel skills to be able to create pivot tables, design databases and dashboards.
- Competence in preparing presentations and delivering training to a variety of internal audiences.
- Ability to plan, organise and prioritise tasks to achieve deadlines.
- Emotionally resilient with the ability to work under pressure in a continually changing environment.