Quality Assurance Officer

An opportunity has arisen in the QA Department for an experienced QA Professional to join the team and cover a Maternity Leave on a fixed term basis of up to 1 year. The successful candidate will report to the Quality Assurance Manager.

Key duties and responsibilities:

• The control, preparation, review and approval of Quality documentation.
• Assisting other QA colleagues with developing GMP and quality related training programmes, including delivering training.
• Responsibility for maintaining up-to-date training records for all staff.
• Investigating or reviewing breaches of GMP which may arise in the manufacture, testing and supply of materials.
• Recommending corrective and preventative actions and monitoring implementation of these recommendations.
• Assisting with the scheduling and performance of internal audits with responsibility for the progression and monitoring of corrective actions.
• Performing the review of batch documentation prior to release by the QP.
• Supporting quality projects.

Key attributes/skills:

• Relevant quality experience in a pharmaceutical 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 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.