As the CSV Specialist you will be getting involved in all aspects of the computerised system validation lifecycle primarily for Analytical Instruments but including any software used for GxP work.
This will include assessing computerised systems for compliance with applicable regulations, determining how to configure systems to meet business and regulatory requirements, preparation of validation documentation and supporting those performing the testing.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the CSV Specialist will be varied however the key duties and responsibilities are as follows:
1. Support the validation and operational management of analytical equipment, specialising in computer and control systems validation, as appropriate.
2. Author and review Validation Documentation to ensure validation activities are built into project plans to give compliance with company and regulatory validation standards.
3. Apply strong CSV knowledge and experience of GxP, Software Validation and Software Testing to GAMP5 standards and be aware of changes in legislation relevant to computerised systems validation.
4. You will be working with different people within operations as well as with QA and IT validation specialists so excellent people and collaborative skills will be required. Good project and time management skills will be important to ensure all aspects of CSV project work is kept on track.
To be successful in your application to this exciting opportunity as the CSV Engineer we are looking to identify the following on your profile and past history:
1. Relevant degree in a IT related or Scientific Discipline.
2. Proven industry experience with GxP Software testing of analytical equipment.
3. A working knowledge and practical experience with GxP regulations relating to computerised systems plus 21 CFR part 11 and GAMP5.
Key Words: Computerised System Validation / CSV / CSV Engineer / CSV Specialist / GAMP / GMP / GxP / IT / QA / Software Testing / LIMS / Laboratory Information Management Systems / Validation Lifecycle / Validation / UAT / User Acceptance Testing / Test Script / Test Report / Pharmaceutical
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.
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