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A Computer Systems Validation (CSV) Specialist is required by Careerwise recruitment to work with our Clare based biotech client.

THE ROLE:

* Ensure Validation of all Global and Site Computer systems is planned, effectively tracked, monitored and achieved in accordance with agreed timelines and in compliance with applicable GxP requirements.
* Maintain excellent working knowledge of systems validation, act as site CSV SME's.
* Lead validation activities, ensuring that resources are managed appropriately, all relevant personnel are consulted throughout projects and fit-for-purpose systems are designed and implemented within the project timelines.
* Ensure System Reviews are conducted, providing suggestions to continually improve end user experience and supporting upgrades as required.
* Liaise with the QA Supplier Assurance team to support internal and supplier software audits as applicable.
* Organise training and support to ensure users are proficient in the validation of compliance related computer systems as required.
* Ensure data integrity requirements are maintained in the development, of computer control systems
* Ensure all computer systems are inspection ready and kept in compliance.

REQUIREMENTS:
* Relevant 3rd level degree.
* Minimum of 5 years experience working in a GxP environment with focus on QC / Process / IT compliance and CSV.
* Preferable to have experience in a commercial Biologics Manufacturing site.
* Detailed understanding of GxP regulations and guidelines with regards to computer system validation and operation in a pharmaceutical manufacturing environment.

N.B. It is essential that you hold a valid working visa for Ireland