Quality OfficerApply Now
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Why this role is important for CPI’s work
CPI has an opportunity for an experienced Quality Officer to join the growing Quality team based at our Glasgow site, the Medicines Manufacturing Innovation Centre. The role is offered on a hybrid basis, with a combination of home and a minimum of 2 – 3 days onsite working
Quality is a key foundation of our business and through effective quality management, CPI will continue to add value to the company and help achieve its business goals. The focus of this role is to provide wide-ranging assistance to the quality function, promoting and integrating quality into every aspect of our business.
In this role you will provide wide-ranging assistance to the Quality function, you will carry out a variety of tasks to assist the specific areas of the quality system mainly focusing on the compliance and maintenance of the CPI Biologics pharmaceutical quality system to meet GMP requirements. Specifically the maintenance of systems and control of documentation.
The Medicines Manufacturing Innovation Centre addresses Grand challenges with diverse topics but common aims to make medicine manufacturing better to get treatments to patients faster and cheaper to patients without additional risk to patients.
Maintain consistent and documented compliance with all relevant Safety, Health and Environment (SHE), Quality, and best practice requirements.
Participate in the use of the site Quality Management System including routine system maintenance and the issue of documentation for change controls, deviations, OOS, action plans, and CAPA.
Document controller activities for all controlled documentation including policies, SOPs, and protocols using an electronic Document Management System (Veeva QualityDocs).
Acting as business administrator on Veeva Quality Vaults (QualityDocs, Training, and QMS).
Control and issue of manufacturing documentation.
Compile batch certification documents for compliance with EU GMP requirements.
Participation in root cause analysis investigations arising from deviations, OOS, and complaints as required.
Assist with both internal and external audits including participation in audits, writing reports, agreeing on CAPA, and following these up as required.
System maintenance and the issue of documentation for the supplier assessment program including audits, supplier evaluation, and technical quality agreements.
Logging and issue of risk assessments, calibration, qualification, and validation documentation as required.
Conducting Product Quality Reviews as required.
Maintenance of the system for customer product quality complaints received at the site.
Assisting in the development, collating, and reporting of trends and key quality metrics.
Assisting the Quality Specialists with any other requirements as required.
The person we are seeking
You will be educated to a minimum of A‑Level/SQA Higher Level (or equivalent) with good maths, IT, and literacy skills and hold extensive industrial experience. Ideally, you will be educated to a Degree level (or equivalent) in a Scientific/Engineering discipline plus hold relevant industrial experience
It is essential that you have knowledge of EU GMP Guidelines including Annexes 11, 13 & 15.
You will also exhibit professional mastery of principles and practices in GMP quality systems, gained in industrial environments.
You will have demonstrable quality system expertise and experience in operating within a GMP environment and maintaining and monitoring quality systems.
Have the confidence to use your own judgment and initiative within standard quality practices, as well as an understanding of when to seek advice from colleagues.
You will have strong attention to detail with a thorough approach and good organisational skills., with the ability to apply theoretical and practical quality tools and techniques to contribute to business activities.
Ability to work in a fast-paced environment, with the flexibility to adjust moving priorities and ensure attention to detail remains first class.
Can demonstrate evidence of knowledge transferring and network-building practice across teams or groups and can provide examples of utilising cross-team working to achieve desired results.
It would be great if you had the following, however not essential:
Membership of a relevant professional body, ideally with Chartered status with a professional institution
Knowledge of ISO 9001 Quality Management System Standards
Knowledge of EU GMP Guidelines Annexes 1 & 2.
Experience in the use and implementation of Electronic Document Management systems and QMS.
What does CPI offer you?
At CPI, we offer a wide range of benefits to our employees, this includes:
- Up to 36 days holiday, including bank holidays – Plus a holiday purchasing scheme
- Generous pension scheme
- Life assurance and accident insurance schemes
- Flexible working
- Learning and Development Opportunities
- Free parking
Find out more about our culture and benefits.
CPI is an organisation based in the UK. Commencement of employment is conditional to demonstrating right to work in the UK, sponsorship may be available.