Job Reference: J5634605
Updated On: 08/04/2021
Status: Open to Applications
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Role OverviewAn exciting opportunity for a CSV Specialist to join a leading company based in the Hertfordshire area. As the CSV Analyst you will report directly to the IT Systems Project Manager and will be involved in all aspects of testing on IT Projects for GxP systems and ensuring that all test plans and case are correctly documented and executed and that these test reports to the highest quality standards.
Key Duties and ResponsibilitiesYour duties as the CSV Specialist will be varied however the key duties and responsibilities are as follows:
1. You will take the lead in computer system validation and compliance, manage and deliver specific Validation Projects according to the business priorities, including work scheduling.
2. You will write, review and approve validation documentation including protocols and reports and manage the timely closure of any discrepancies or non-conformities.
3. As the CSV Specialist you will maintain the ongoing compliant status of computer systems associated with equipment, facilities and utilities by involvement of the scheduling of activities and provide a reliable service to our internal customers to ensure that time scales are met and work is carried out to meet expectations.
4. You will undertake all work in accordance with Code of Safety Practice and site Quality Policies
Role RequirementsTo be successful in your application to this exciting opportunity as the CSV Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Science, Engineering or IT related discipline or equivalent.
2. Proven industry experience in of generating, executing and reviewing validation protocols, reports and technical documents.
3. A working knowledge and practical experience with EU and FDA regulatory requirements relating to validation including (but not limited to) UK/EU GMP Annex 11 and 21 CFR Part11, and technical understanding of computerised systems including PLCs, SCADA, networked systems, laboratory systems, databases, layered software as used in a GxP environment.
Key Words: Computerised Systems | Validation | Pharmaceutical | BioPharmaceutical | Manufacturing | GMP | PLC | SCADA | Documentation| GAMP | CAPEX |
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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