IS Compliance Specialist - Cambridge
Posted on Jul 3, 2019 by CV-Library
Our client is a global pharmaceutical company who specialise in the development of a portfolio of cannabinoid prescription medicines in a wide range of therapeutic indications.
This role is based in Cambridge, and can be easily reached by main transport links.
Responsible for providing IS Compliance and CSV support for our client global Information Technology systems and related environments. The role holder will work as part of the Infrastructure Services (IS) Compliance team responsible for the generation, review and approval of IT Qualification and Validation documents.
- Serve as a Subject Matter Expert (SME) to provide regulatory guidance and support to the Global IS team on applicable regulatory matters.
- Author, review, assist with development and approve (as appropriate) the generation and execution of compliance documentation for:
- Qualification and Validation (IQ/OQ/PQ test scripts).
- Technical Design Specifications.
- User & Functional Requirement Specifications (UFRS).
- Standard Operating Procedures, guidelines and processes.
- Provide support for assessment of new and existing suppliers through quality system audits and assessments to ensure compliance.
- Solid experience working in an IT compliance or computer system validation role within a pharmaceutical, regulated or ISO environment.
- Educated to degree level or equivalent, in an IT field, or equivalent technical discipline.
- Knowledge and understanding of IT best practices and IT quality Management Systems (such as ITIL, ISO).
- Knowledge and practical experience of the application of cGxP, GAMP5, 21 CFR Part 11, SOX and other relevant health authority regulations, and the importance of quality and risk management.
- Working knowledge of the system/software design lifecycle, IT project management and development of validation/qualification documentation within a regulated environment.
- Knowledge and experience of deployment of enterprise-class ERP, eQMS, eDMS, eTMF, CTMS, networking, backup and infrastructure technologies including Active Directory, Group Policy management, DNS, DHCP and WSUS and IS Security and familiarity with a range of desktop and mobile operating systems and good understanding of IT Concepts and terminology.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45954 in all correspondence
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