CPI is looking to recruit a Quality Specialist to provide wide ranging support to the quality function, promoting and integrating quality into every aspect of our business. In this role, you will perform a variety of tasks in support of specific areas of the quality system mainly focusing on the implementation, sustainability and continued improvement of the CPI Biologics quality management system to meet GMP requirements.

Key tasks in the Quality Specialist role will include (but are not limited to the below), please download the job description for full details available on the CPI careers page:

• Embrace and role model the desired behaviours to exemplify our Company values, promoting an ethical, positive company culture.
• To maintain consistent and documented compliance with all relevant Safety, Health and Environmental (SHE), Good Manufacturing Practice (GMP), Data Integrity (DI), quality and best practice requirements.
• Support the site Quality Management System including routine review and approval of change controls, deviations, OOS, action plans and CAPA and supporting the supplier evaluation process.
• Compile and review batch certification documents for compliance with EU GMP requirements.
• Assist in the resolution of manufacturing, testing, and packaging issues to support the release of products.
• Participation in root cause analysis investigations arising from deviations, OOS, and complaints.
• Support both internal and external audits including writing reports, agreeing CAPA and following these up as required.
• Review and approval of risk assessments and validation documentation as required.
• Conducting Product Quality Reviews as required.

This is a transformative role at the intersection of automation and novel pharmaceutical innovation!

As an ambassador for our Automation team, your focus will revolve around the challenges set by the Medicines Manufacturing Innovation Centre (MMIC) based in Glasgow, propelling the delivery and perpetual enhancement of automation systems for groundbreaking GMP innovation projects.

Why we need you

Leveraging your technical expertise to provide invaluable input, orchestrating the installation, networking, testing, and verification of automation projects within the dynamic landscape of GMP innovation, you will be an authority in automation, networking, cloud technology, and data science, where your solutions will spearhead innovation and play a pivotal role in the development and improvement of cutting-edge digital manufacturing approaches. Your influence extends beyond the physical boundaries of automation, positioning you as a key contributor to transformative advancements.

Guided by the technical supervision of your line manager and esteemed senior technical colleagues, you'll navigate this dynamic role with a structured approach to problem solving, managing key stakeholders, internal and external.

Beyond your core responsibilities, your impact will reach into diverse supporting activities—ensuring the seamless delivery of Safety, Health, and Environment (SHE) standards, and championing continuous improvements in quality.

Join us in a space where government-driven initiatives converge with pharmaceutical innovation, and your role not only meets business unit objectives but propels the entire industry into new realms of achievement. Elevate your career in an environment that thrives on innovation, fosters collaborative excellence, and drives impactful change!

Take a glimpse into the future with Grand Challenge 2, a project that promises to redefine just-in-time clinical trials.

Explore the project details here.

You can also get an insight of what it is like to work at the MMIC here.

Key responsibilities

Key tasks in the OT Engineer role will include (but are not limited to the below), please download the job description for full details available on the CPI careers page:

• To plan and deliver networking activities to ensure a the OT Network is secure and maintained.
• To collect, parse, assimilate and analyse data from multiple process streams and sources for innovative project.
• To be responsible for the successful delivery of experiments on automation projects.
• To maintain clearly documented records of technical data, decisions, methodologies, ensuring the experimental plan aligns with the validation masterplan and other relevant quality documents within the GMP framework.
• To engage in and actively contribute to a culture of continuous capability development, providing insights into areas of specialism.