J563161OxfordshirePharmaceutical PermanentDependent on Experience Full Time23/10/2018Quality Assurance – Compliance Quality Assurance - Validation Quality Assurance – GCP IT Quality Assurance – CSV Quality Assurance - GxP
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An exciting opportunity for a Quality CSV Manager to join a leading company based in the Oxfordshire area has become available. As the Quality CSV Manager, you will be responsible for validating all current and proposed information systems to ensure regulatory and business compliance, as well as be responsible and accountable for the validation of all computer systems and the coordination of changes to existing systems and prospective implementations.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Quality CSV Manager, will be varied however the key duties and responsibilities are as follows:
1. You will take the lead role in establishing a comprehensive and robust framework for computer systems compliance.
2. You will assist and advise the organisation's IT, QA and Senior Management Team on any computer systems validation and compliance activities.
3. As the Quality CSV Manager you will provide leadership and guidance to functional management with regards to CSV best practise to deliver efficient and compliant IT projects.
4. You will mentor and coach staff in computer systems related topics, and provide computer systems compliance support during client audits and regulatory inspections.
To be successful in your application to this exciting opportunity as the Quality CSV Manager, we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Science or Computer Science related discipline.
2. Proven industry experience of writing computer systems validation plans and reports, as well as experience with reviewing and approving documentation.
3. A working knowledge and practical experience with CSV Standards and processes, and knowledge of IT software and infrastructure projects. Understanding of cGXP guidelines is also advantageous.
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.