Quality Assurance Officer

An opportunity has arisen in the QA Department for an experienced QA Professional to join the team. The successful candidate will report to the Quality Assurance Manager.

Key duties and responsibilities:

• To provide support to the Quality Assurance Manager / Responsible Person as directed.
• To assist in implementation/maintenance of GxP cross-company QA processes.
• To provide induction and refresher training in GxP disciplines.
• To assist in updating and maintaining WDA(H) documentation.
• To assist in creating and updating GDP and Quality related processes and documentation.
• To provide support with the Supplier Quality Incident process.
• To provide support with the Deviation/CAPA process.
• To provide data for the Kempston Operational & Quality, Aeropak Technical and Management Review meetings.
• To maintain and distribute Supplier related documentation as requested by relevant Department(s).
• To maintain and develop professional skills by attending professional courses and other forums.
• To perform QA Internal Audits and Report in a timely manner, and to support external supplier audits, when required.

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; GDP/GMP, or any other GxP area, regulatory and accreditation systems, and quality management.
• 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.