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Senior CSV Specialist



Business Type: Medical Devices Company
Job Type: Information Technology
Job Level: Experienced (non manager)
Position: Full Time
Location: Ireland (Eire)
Reference: 237134
Closing Date: 30/09/21
Job Details:

We are looking for a Computer System Validation Specialist for an international Medical Devices company to join the team in Galway, Ireland.

This person will be responsible for the building and maintenance of the Computer System Validation and Compliance program for part of the Company''s Health Tech market segment. You will work with Global Quality, Enterprise Architecture and IT Platform Leads to execute validation. You will be responsible for all aspects of computer system validations and associated testing. This includes development of User Requirements and testing that meet FDA & ISO standards.

Main requirements:

- 6 years+ of computer validation experience in the medical device manufacturing industry or equivalent.

- Experience in a regulated environment with in depth knowledge and experience with cGMPs/GLPs/GAMP regulations related to medical device manufacturing systems, CFR Part 820, 210, 211, 21 CFR Part 11, ISO 13485, ISO 14971.

- Relevant experience on Client/Server applications; RDMS Database (SQL Server) applications; SAP system, CA Validator, Equipment Control validation (PLC/SCADA), Network and Enterprise Content Management Systems and cloud/SaaS applications.

What we offer:

- relocation package ( 4-8 months project in another location)

- competitive salary

- career progression

If you are interested please do not hesitate to apply and we will be happy to get in touch for more information.

Hope to hear from you soon!



NonStop Consulting Limited Posted by:: NonStop Consulting Limited (View all our vacancies)
Unless otherwise stated, if applying for a job, you must ensure that you are already authorised to work in the country in which the job is based
Posted: 23/09/2021 | NPJ Ref: 283317 | NPJ Original URL
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