Why this role is important for CPI’s
work
We’re looking for an experienced eCompliance and Quality Systems Specialist to ensure our computerised systems meet the highest standards of compliance and integrity. This is a key role in maintaining validated systems and driving continuous improvement across our Technology Centres and supporting functions.
Key tasks in the eCompliance and Quality Systems 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:
1. Provide quality oversight for computerised systems, ensuring compliance with ISO, GxP, Data Integrity, and GAMP 5 standards.
2. Maintain validated status of CPI’s eDMS and eQMS systems.
3. Lead assessments and implementation of new quality system features.
4. Act as QA Single Point of Contact for CSV and eCompliance initiatives.
5. Support audits, inspections, and remediation activities.
6. Drive continuous improvement and training for stakeholders on CSV processes.
The person we are seeking
It is essential that you are educated to HNC or Foundation Degree level (or equivalent) in a Scientific/ Engineering discipline plus significant industrial experience. It is also essential that you possess significant eCompliance, data integrity or computer system validation expertise and experience of operating within a GMP environment, developing, implementing and monitoring quality systems. Along with Detailed knowledge EU GMP Guidelines Annexes 11 & 15, Data Integrity Guidelines and ISPE GAMP 5.
What does CPI offer you?
At CPI, we offer a wide range of benefits to our employees, this includes:
7. Up to 36 days holiday, including bank holidays – Plus a holiday purchasing scheme
8. Generous pension scheme
9. Life assurance and accident insurance schemes
10. Flexible working
11. Learning and Development Opportunities
12. Free parking