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Quality Specialist

3 months ago


Glasgow, United Kingdom Centre for Process Innovation Full time

**About **CPI**:
CPI helps make great ideas and inventions a reality. We’re a team of intelligent people using advances in science and technology to solve the biggest global challenges in healthcare and sustainability.

Through our incredible people and innovation infrastructure, we collaborate with our partners in industry, academia, government, and the investment community to accelerate the development and commercialisation of innovative products.

From health technologies and pharmaceuticals to sustainable food and materials innovations, we turn the entrepreneurial spirit and radical thinking of our people and partners into incredible impact that makes our world a better place.

**Why this role is important for CPI’s work**:
CPI is currently recruiting for an exciting opportunity for a Quality Specialist to join its expanding quality team as we open a new state-of-the art facility in 2025; the Oligonucleotide Manufacturing Innovation Centre of Excellence will be the second centre opened by CPI within the Advanced Manufacturing Innovation District Scotland (AMIDS).

The centre will drive innovative manufacturing techniques in an emerging area of medicine known as oligonucleotides, specifically focusing on new processes that are faster and more sustainable.

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 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 Medicines Manufacturing Innovation Centre (MMIC) quality management system and expansion to the Oligonucleotide Manufacturing Innovation Centre of Excellence to meet GMP requirements.

**The person we are seeking**:
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:

- To maintain consistent and document 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.
- Author, review and approval of documentation including policies, SOPs and protocols and manufacturing documents.
- 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.
- Participation in the supplier assessment program including audits, supplier evaluation and technical quality agreements.
- Review and approval of risk assessments and validation documentation as required.
- Assisting in the development, collating and reporting of trends and key quality metrics.
- Compile and review batch certification documents for compliance with EU GMP requirements.
- Coordinating customer product quality complaints.

**Essential**:

- Educated to HNC or Foundation Degree level (or equivalent) in a Scientific/Engineering discipline plus significant industry experience or Educated to Degree level (or equivalent) in a Scientific/Engineering discipline plus relevant industry experience.
- Will possess significant quality system expertise and experience of operating within a GMP environment, developing, implementing and monitoring quality systems.
- Will exhibit professional mastery of principles and practices in GMP quality systems, gained in industrial environments.
- Strong attention to detail with a thorough approach and good organisational skills.
- Ability to work in fast paced environment, flexibility to adjust with moving priorities and ensuring attention to detail remains first class.
- Can demonstrate evidence of knowledge sharing and network building practice across teams or groups.
- Can provide examples of actively utilising cross-team collaboration to achieve desired results.
- Has confidence to use own judgement and initiative within standard quality practices, as well as an understanding of when to seek advice from colleagues.

**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.

**Additional information**:
CPI is an organisation based in the UK. Commencement of employment is conditional to demonstrating right to work in the