J56233CambridgeshirePharmaceutical Engineering PermanentDependent On ExperienceFull Time12/06/2018Biochemistry – Development / Validation Quality Assurance - Validation Quality Assurance – GMP Engineering Engineering – Control / Automation Engineering – Validation IT – Automation Quality Assurance – CSV Quality Assurance - GxP
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An exciting opportunity for a QA CSV Specialist to join a leading pharmaceutical company based in the Cambridge area has become available. As the QA CSV Specialist you will be responsible for providing validation expertise in the lifecycle management of all aspects of computer system validation (CSV), qualification, data integrity and regulatory compliance activities.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the QA CSV Specialist will be varied however the key duties and responsibilities are as follows:
1. You will maintain and manage quality systems regarding GAMP and cGMP for the site.
2. You will support and perform internal and third party audits and inspections to assure compliance with regulations and drive continuous improvements.
3. As the QA CSV Specialist you will manage the scheduling of Periodic and Security Reviews and ensure adherence to these schedules.
4. You will keep up to date on regulations and legislation with respect to CSV and evaluate the affect of new or changed laws and practices on current operations.
To be successful in your application to this exciting opportunity as the QA CSV Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a science or engineering, computing or pharmaceutical related subject area.
2. Proven industry experience on GAMP related projects for multiple aspects of IT and/or process control systems.
3. A working knowledge and practical experience with Quality Management Systems, cGMP, Annex 11 and 21 CFR Part 11.
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.