Quality Assurance Officer
- Edinburgh
- Permanent
- Full-time
- The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career.
- A generous salary package – we reward our people at the level they deserve.
- 31 days of annual leave, plus 4 public holidays which increases with tenure.
- A competitive company pension scheme to help you save for the future.
- Group Life Cover – you are automatically covered for three times your basic salary to give you and your family peace of mind.
- Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us.
- Flexible benefits such as retail discounts and access to the Cycle2Work scheme.
- An exciting opportunity for a Quality Assurance Officer to join our Quality team.
- Your primary role will be to support the Quality Department with all activities related to maintenance of the Quality Management System.
- Reviewing Standard Operating Procedures (SOPs) to ensure compliance with company policies, practices and relevant standards and guidelines.
- Writing SOPs and updating SOPs for QA activities.
- Administering, reviewing and approving Incident Reports, Change Controls and Risk Assessments.
- Performing data review audits (Batch Production Records, Validation Documents and Development Documentation as required).
- Performing internal audits to determine compliance with GMP and identify areas for improvement.
- Issuing, reviewing and closing Corrective and Preventative Actions (CA/PAs).
- Reviewing and approving suppliers / service providers including supporting with audits of critical suppliers where required.
- Experience in a similar role within a relevant industry (e.g. pharmaceutical industry / stem cell activities).
- Previous experience in a GMP environment.
- A clear understanding of GMP, regulatory and accreditation systems and quality management.
- Proven experience in the maintenance of an electronic Quality Management System.
- Have excellent influencing, communication, interpersonal and, motivational skills.
- An ability to take decisions, to analyse information in a logical manner and to prepare coherent investigative and/or technical reports.
- Competent in computer packages including Microsoft Office and an electronic quality management package.
- The candidate must be able to multitask, have excellent attention to detail and time management skills.
- Excellent administration and record keeping skills.
- Educated to degree level in a Life Sciences discipline.