Qualified Person at RoslinCT

City of Edinburgh, Scotland, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

14 Jan, 26

Salary

0.0

Posted On

16 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Qualified Person, Quality Management System, GMP, Biologics, Aseptic Manufacturing, Investigational Medicinal Products, Team Leadership, Decision Making, Regulatory Knowledge, Continuous Quality Improvement, Batch Review, SOP Writing, Analytical Skills, Adaptability, Customer Focus, Quality Assurance

Industry

Biotechnology Research

Description

Qualified Person 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 We are looking for a Qualified Person to join our expanding team here at RoslinCT. Please note - this is a permanent opportunity, not a consultancy role. The primary function of this position is to serve as a named Qualified Person, to influence the quality agenda and support the maintenance of the QMS to ensure it complies with all relevant legislative requirements. You will be expected to provide a QP function for licenced ATMPs according to the relevant directives and guidelines. You will conduct QP review of executed batch manufacturing records and certify as defined under SI2012/1916 and under the terms of the Company’s MIA and MIA(IMP) and relevant regulatory filings (MA, IND, IMPD as applicable). Support and develop a culture of continuous quality improvement, ensuring all RoslinCT staff understand our quality management system and the impact of quality on, patients, our customer service and perception. Support the process of batch review and release and coordinate with Quality peers performing batch review duties as necessary. Partner with fellow QPs and the Head of Quality on deployment of QPs to individual projects (Clinical and Commercial) and PQS reviews as applicable. Ensure GMP is maintained in the facilities and anticipate and develop plans for the implementation of legislative changes to QMS, systems, processes and procedures, including support for GMP training on site. Write, review, approve and maintain Quality SOPs applicable to key areas of the PQS as required. About you You can perform the duties of a Qualified Person under the provision of Directive 2001/83/EC and Directive 2001/82/EC. You will have a degree (or equivalent qualification) in Biology, Chemistry or Pharmacy (or equivalent qualification). Experience of working in a Pharmaceutical Quality department in a commercial manufacturing environment. In depth knowledge about biologics, aseptic manufacturing, and investigational medicinal products. Experience in leading, managing, and engaging a team. Ability to take decisions and to analyse information logically. A clear understanding of GMP, regulatory, and quality management. An ability to adapt to change, understanding business needs and a focus on solution and customers. 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. 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 jobs@roslinct.com. We’re here to assist and make things as smooth as possible for you.

Responsibilities

The primary function of this position is to serve as a named Qualified Person, influencing the quality agenda and supporting the maintenance of the Quality Management System. Responsibilities include conducting QP reviews of batch manufacturing records and ensuring compliance with relevant directives and guidelines.