J562888OxfordshirePharmaceutical PermanentDependent on Experience Full Time03/01/2019Quality Assurance – Compliance Quality Assurance - Validation IT – Systems Engineering IT - Hardware Quality Assurance – CSV Quality Assurance - GxP
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An exciting opportunity for a CSV and Infrastructure Analyst to join a leading company based in the Oxfordshire area has become available. As the CSV and Infrastructure Analyst you will be responsible for the validation and compliance of IT GxP and non GxP systems within the company, including corporate, laboratory and manufacturing systems.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the CSV Infrastructure Analyst will be varied however the key duties and responsibilities are as follows:
1. You will assist to design and implement a New IT Quality Framework and take responsibility for management and delivery of IT GxP projects.
2. You will act as primary POC between QA and IT for computer system validation activities.
3. As the CSV and Infrastructure Analyst You will review documents for IT systems installations and implementation (DQ/IQ/OQ/PQ), test plans/scripts, validation summary reports and implement GAMP5 guidelines as appropriate.
4. You will Generation review and approve Quality and Validation documentation and act as a source of advice and guidance on Quality / GxP Issues with special reference to validation.
To be successful in your application to this exciting opportunity as the CSV and Infrastructure Analyst we are looking to identify the following on your profile and past history:
1. Relevant degree in a Computer Science related discipline or significant experience working in a CSV position or similar.
2. Proven industry experience in IT Quality and computer validation within the pharmaceutical industry, and experience of working in GAMP Good Practice Guide on IT infrastructure control and Compliance.
3. A working knowledge and practical experience with writing SOPs and validation documentation (protocols/reports) as well as a knowledge of modern IT hardware, software architecture and IT infrastructure concepts.
Key Words: CSV | IT Quality | Compliance | Infrastructure | GAMP 5 | 21 CFR Part 11 | Validation | GxP | Quality Systems | LIMS | FDA | GMP |
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.