eCompliance and Quality Systems Specialist
| Dyddiad hysbysebu: | 28 Tachwedd 2025 |
|---|---|
| Cyflog: | £38,000 i £47,600 bob blwyddyn |
| Oriau: | Llawn Amser |
| Dyddiad cau: | 07 Rhagfyr 2025 |
| Lleoliad: | Darlington, County Durham |
| Gweithio o bell: | Hybrid - gweithio o bell hyd at 3 ddiwrnod yr wythnos |
| Cwmni: | Centre for Process Innovation |
| Math o swydd: | Parhaol |
| Cyfeirnod swydd: | CPI-11522-25 |
Crynodeb
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:
• Provide quality oversight for computerised systems, ensuring compliance with ISO, GxP, Data Integrity, and GAMP 5 standards.
• Maintain validated status of CPI’s eDMS and eQMS systems.
• Lead assessments and implementation of new quality system features.
• Act as QA Single Point of Contact for CSV and eCompliance initiatives.
• Support audits, inspections, and remediation activities.
• Drive continuous improvement and training for stakeholders on CSV processes.
The Person:
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.
Closing date: 7 December 2025
Stage one teams interview: week commencing 15 December 2025
Stage two face to face interview: week commencing 12 January 2026
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:
• Provide quality oversight for computerised systems, ensuring compliance with ISO, GxP, Data Integrity, and GAMP 5 standards.
• Maintain validated status of CPI’s eDMS and eQMS systems.
• Lead assessments and implementation of new quality system features.
• Act as QA Single Point of Contact for CSV and eCompliance initiatives.
• Support audits, inspections, and remediation activities.
• Drive continuous improvement and training for stakeholders on CSV processes.
The Person:
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.
Closing date: 7 December 2025
Stage one teams interview: week commencing 15 December 2025
Stage two face to face interview: week commencing 12 January 2026
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