Quality Engineer

Quality Engineer

Location: Edinburgh BioQuarter

Who are we?

We are RoslinCT, a world leading cell and gene therapy contract development and manufacturing organisation creating cutting edge therapies that change people's lives.

Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life changing products utilising ground breaking science.

Find out more about what we do here!

Why join us?

• 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.

Your new role

• An exciting opportunity for aQuality Engineer to join our Qualityteam. The Quality Engineer will support and enhance the effective operation of the Quality Management System (QMS), with a primary focus on quality risk management and quality improvement projects.
• You'll be responsible for:
• Developing, implementing and continuously improving the quality risk management process, ensuring alignment with regulatory expectations and business needs.
• Maintaining the quality risk register, ensuring risks are clearly articulated, assessed, prioritised, reviewed and escalated appropriately.
• Promoting and embedding risk based thinking across the organisation through guidance, coaching and training.
• Designing and delivering risk management training and supporting materials for operational and quality teams.
• Ensuring risks arising from deviations, investigations, audits, changes and quality improvement activities are captured and linked to the risk register.
• Leading root cause analysis and risk assessments to identify systemic and emerging risks.
• Monitoring and assessing the effectiveness of risk mitigation actions and CAPAs, escalating residual risks as required.

About you

• Significant experience working within a GMP regulated environment.
• Exceptional working knowledge of GMP standards, with practical application of quality risk management principles.
• Prior experience with developing and maintaining quality risk management processes and risk registers to ICH Q9 framework.
• Strong QMS knowledge and associated records (deviations, investigations, CAPAs, and change controls).
• Ability to lead or facilitate risk assessments and root cause analysis.
• Demonstrated experience with training or coaching quality teams, and supporting with internal, client and regulatory audits.
• Competent IT skills; particularly with Microsoft Word, Excel and electronic QMS systems.

Qualifications

• A degree in Life Sciences or a related field, or equivalent experience within a regulated GMP environment.

Next Steps

If this sounds like you, then please hit 'Apply' now. We will ask you to upload your CV and complete a short application form detailing why you are interested and why we should hire you.

At RoslinCT, we're all about inclusivity and creating a fair, welcoming workplace. Our goal is to make sure everyone knows they're valued and encouraged to be themselves, whether they're our employees, customers, or partners.

We take pride in being an equal opportunity employer. We treat all applicants fairly and don't discriminate based on any protected characteristics. So, no matter who you are, we welcome your application with open arms.

If you've got any specific needs or concerns regarding accessibility during the recruitment process, don't hesitate to reach out to us at . We're here to assist and make things as smooth as possible for you.