Quality Assurance Officer - QMS
Location: Edinburgh BioQuarter/Shawfair
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
Due to the nature and training requirements of this role, applicants must have the legal right to work in the UK with sufficient permission to meet the needs of the position. We are unable to provide visa sponsorship for this role under Home Office restrictions.
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 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.
About you
* 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.
Qualifications
* Educated to degree level in a Life Sciences discipline.
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.