Quality SpecialistApply Now
At CPI we work with our partners to translate inventions into products and processes that enhance health and well-being, protect and improve our environment and increase productivity across industries.
With a deep understanding of innovation processes and funding, outstanding technical expertise and industry relevant assets, we enable products and processes to be quickly and cost-effectively brought to market. This supports the development of next-generation manufacturing, highly-skilled jobs and economic growth for the UK.
Our partners operate across many diverse markets including pharmaceuticals, speciality chemicals, food and drink, electronics and transportation.
Why this role is important for CPI’s work
CPI has an opportunity for an experienced Quality Specialist to join a new and growing team based at the new Medicines Manufacturing Invocation Centre (MMIC), located in Renfrewshire. This state-of-the-art facility will solve major pharmaceutical industry challenges and accelerate access to affordable medicines.
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 continuous improvement of the CPI Medicines Manufacturing Innovation Centre (MMIC) quality management system to meet GMP requirements.
Projects within CPI encompass a broad range of process technologies and novel measurement and analytical techniques, and this is reflected in the diversity of customers and their expertise.
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.
Review, approval and issue of manufacturing documentation.
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.
Participate 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
Participate in the supplier assessment program including audits, supplier evaluation and technical quality agreements.
Review and approval of risk assessments and validation documentation as required
Conduct Product Quality Reviews as required.
Coordinate customer product quality complaints received at the site.
Assist in the development, collating and reporting of trends and key quality metrics.
Maintain consistent and documented compliance with all relevant Safety, Health and Environment (SHE), Quality and best practice requirements.
The person we are seeking
We are looking for an individual who:
Possess significant quality system expertise and experience of operating within a GMP environment, developing, implementing and monitoring quality systems.
Exhibits professional mastery of principles and practices in GMP quality systems gained in industrial environments.
Has demonstrable attention to detail skills, with a thorough approach and good organisational skills.
Has the ability to work in a 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.
Has an ability to apply theoretical and practical quality tools and techniques to contribute to business activities.
Can provide examples of actively utilising cross-team collaboration to achieve desired results.
Has the confidence to use own judgement and initiative within standard quality practices, as well as an understanding of when to seek advice from colleagues.
Possesses knowledge of EU GMP Guidelines Annexes 11 & 13.
Has experience in the implementation and use of electronic/digital systems for operational activities, including QMS.
Holds Pharma or Medical device operational experience, with exposure to external audits (regulators or customers)
It is required that candidates are educated to HNC/Foundation Degree in a Scientific/Engineering discipline, as a minimum. Candidates will also need to be able to demonstrate significant relevant industrial experience.
It is preferred that candidates also have the following:
Hold chartered status with a relevant professional institution.
Member of a relevant professional body.
Knowledge of ISO 9001 Quality Management System Standards.
Knowledge of EU GMP Guidelines including Annexes 1, 2 & 15.
What does CPI offer you?
At CPI, we offer a wide range of benefits to our employees, this includes:
- Up to 33 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.