CSV Specialist

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

Please call Michael O'Connor today for further information on 091-452410 or email moconnor@careerwise.ie


CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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