An exciting opportunity has arisen within the Quality Assurance team of RoslinCT for a Quality Systems Engineer to support the development and implementation of GMP compliant electronic systems within the company. RoslinCT is a leading Cell and Gene Therapy CDMO based in Edinburgh and currently expanding to meet the growing manufacturing demand within the field. We are looking for an individual who shares our passion for Quality and delivering an excellent service to our clients.
Candidates for this role must also be able to demonstrate a strong commitment to our Core Values, and so should be:
* Able to demonstrate exceptional leadership skills
* Passionate about Customer Satisfaction
* Able to support a ‘one team’ approach
* A great communicator
* Committed to personal growth and development
* Accountable for their work
As Quality Systems Engineer, the primary function will be to drive the development of our electronic Quality Management System, implementing new functionality and improving existing processes. In addition, the company plans to introduce new digital systems for other parts of the business and the post holder will play a key role in their evaluation and deployment.
There will be opportunity for the position to grow as the company expands its operation and introduces these new systems.
* Supporting the administration of the company’s Q-Pulse documents management system. Assist in the transfer process of paper-based QMS to Q-Pulse and its validation and in the introduction of new Q-Pulse modules and their validation. Provide training and support to staff using Q-Pulse modules as per Company requirements.
* Assist in the evaluation, implementation and validation of new computerised systems. Prepare SOPs and training materials to assist with new technology on boarding processes.
* Perform data integrity assessments. Assist with Quality related aspects of the general business IT infrastructure, security and management.
* Assist in the generation of KPI’s for management meetings.
* Ensure that controlled documents as part of the quality system are prepared, issued, managed and updated in compliance with Good Manufacturing Practice.
* Performing document management duties as required. Maintenance of reliable document storage and archiving systems, both paper based and electronic to ensure integrity of the records.
* Supporting the QA Manager with hosting client and regulatory audits. Demonstrate excellent customer service skills for both internal and external customers.
* Compliance with all Health and Safety policies and procedures.
The Quality Systems Engineer will have an honours degree in a computer science or related subject qualification, or alternatively they will have a scientific qualification with suitable experience implementing computerised systems in a scientific GMP setting.
The Quality Systems Engineer will have:
* Experience within a GMP Quality Department.
* A working knowledge of GAMP5, 21CFRPart 11. Experience in using Q-Pulse Document Management system or similar system would be desirable.
* Experience of quality support for IT systems and software, including validation. Demonstrable knowledge of IT infrastructure and its operation.
* Excellent administration skills.
* Excellent presentation skills and ability to condense complex data for trending purposes. Excellent data recording and record keeping skills with a good eye for detail.
* Organisational and planning skills with the ability to plan ahead whilst delivering results to deadline.
This is an exciting role and the successful candidate will be able to demonstrate the following behavioural competencies:
* Emotional resilience and an ability to work under pressure with a "can do attitude".
* Ability to process a high volume of planned and un-planned work effectively. The ability to multitask and manage time effectively to ensure all work streams are managed.
* A determination to continually develop and improve our processes.
* Effective communicator with the ability to build strong working relationships
* The ability to provide constructive feedback for issues affecting Quality
* Keen to learn and share knowledge with the whole team. A team player with the ability to work unsupervised
* Conscientious and takes personal responsibility for own actions and behaviours. Understands the needs of the customers and responds accordingly to deliver excellent customer service.
* Group Personal Pension Plan: 3% Employee contribution with an Employer contribution of initially 5% for the first year of joining the scheme then a 1% increase per year until a maximum of 8% is reached.
* Group Life Cover, 3X Salary. Health4All Cash Plan where you are able to claim cash back towards dental check-ups and treatment, new glasses, contact lenses and therapy treatments such as physiotherapy and chiropody and more. Employee Assistance Programme.
* 31 days annual leave with an extra day from 3 years’ service and a further day from 5 years’ service. 4 public holidays
Location: Edinburgh and Lothian. Please ensure that you can realistically commute to our site before applying, as we have limited parking spaces available
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