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 workQuality 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 Quality oversight across the use and implementation of computerised systems and to ensure CPI computerised systems operate within the framework of regulations or standards (ISO, GxP, Data Integrity and industrial standards such as GAMP 5) and applicable internal procedures. In this role, you will work across CPI’s Technology Centres and Supporting Functions to assist in the creation or review of internal computerised system and data integrity related initiatives, including the development, execution and approval of protocols, the issuance and approval of validation reports, and the execution of activities as defined within the data integrity strategic plan. The role requires active participation in internal e‑compliance and initiatives such as process improvements, and periodic reviews.
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.
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Key tasks in the eCompliance 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 documented compliance with all relevant Safety, Health and Environment (SHE), Quality, Good Manufacturing Practice (GMP), Data Integrity (DI), quality and best practice requirements.
- Act as QA Single Point of Contact for all CSV related matters for Computerised Systems and act as an interface between IT and Business for eCompliance topics in relation to classified Computer Systems promoting a Quality Culture.
- Support the IT Architecture and Security, and Information System Teams, and the Computer System Validation (CSV) & Validation Leads in compliant deployment and/or implementation of CPI computerised systems.
- Assist with, review, audit, and approve CPI computerised systems procedures, inventories, Validation Master Plans, key validation deliverables, change management deliverables and periodic compliance review.
- Participate in the Continuous Improvement of the CSV and related IT elements of the Quality Management System
- Assist in development of internal training requirements and materials for the different stakeholders involved in CSV projects.
- Assist in preparation and support for internal and external audits and inspections. Provide support for remediation actions, report writing, agreeing CAPA and providing QA Support.
The person we are seekingEssential:
Be educated in line with the below:
- To HNC or Foundation Degree level (or equivalent) in a Scientific/Engineering discipline plus significant industrial experience.
- Educated to Degree level (or equivalent) in a Scientific/Engineering discipline plus relevant industrial experience.
- Educated to Master Degree level (or equivalent) in a Scientific/Engineering discipline plus significant relevant industrial experience.
- Educated to PhD level (or equivalent) in a Scientific/Engineering discipline plus industrial experience in a relevant field.
Have the below relevant experience:
- Possess significant eCompliance, data integrity or computer system validation expertise and experience of operating within a GMP environment, developing, implementing and monitoring quality systems.
- Exhibit professional mastery of principles and practices in GMP quality systems, gained in industrial environments.
- Detailed knowledge EU GMP Guidelines Annexes 11 & 15, Data Integrity Guidelines and ISPE GAMP 5.
- 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.
- Demonstrate scalability in their solutions to ensure a “right size” approach to the problem at hand.
- Demonstrate evidence of knowledge sharing and network building practice across teams or groups.
- Ability to apply theoretical and practical quality tools and techniques to contribute to business activities.
- Confidence to use own judgement and initiative within standard quality practices, as well as an understanding of when to seek advice from colleagues.
It would be great if you also had:
- A member of a relevant professional body.
- Knowledge of ISO 9001/ ISO 14001 / ISO 13485 / ISO 22000 / FSSC 22000 Quality Management System Standards.
- Knowledge of 21 CFR Part 11 & FDA Guidance for Industry: Data Integrity and Compliance with cGMP.
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 informationCPI is an organisation based in the UK. Commencement of employment is conditional to demonstrating right to work in the UK, sponsorship may be available.