Why this role is important for CPI’s
work
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 :
1. Embrace and role model the desired behaviours to exemplify our Company values, promoting an ethical, positive company culture.
2. 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.
3. 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
4. Compile and review batch certification documents for compliance with EU GMP requirements.
5. Assist in the resolution of manufacturing, testing and packaging issues to support the release of products.
6. Participation in root cause analysis investigations arising from deviations, OOS and complaints.
7. Support both internal and external audits including writing reports, agreeing CAPA and following these up as required.
8. Review and approval of risk assessments and validation documentation as required.
9. Conducting Product Quality Reviews as required.
The person we are seeking
Essential:
10. Educated to at least HNC or Foundation Degree Level (though preferably degree level) or equivalent in a Science/ Engineering discipline plus relevant experience. In the absence of a formal qualification, significant relevant experience will be considered
11. Possesses significant quality system expertise and experience of operating within a GMP environment, developing, implementing and monitoring quality systems.
12. Exhibits professional mastery of fundamental knowledge and practices in GMP quality systems, gained in industrial environments.
13. Has confidence to use own judgement and initiative within standard quality practices, as well knowing when to seek advice from colleagues.
14. Has strong attention to detail with a thorough approach and good organisational skills.
What does CPI offer you?
At CPI, we offer a wide range of benefits to our employees, this includes:
15. Up to 36 days holiday, including bank holidays – Plus a holiday purchasing scheme
16. Generous pension scheme
17. Life assurance and accident insurance schemes
18. Flexible working
19. Learning and Development Opportunities
20. Free parking