Computer Systems Engineer

Job type:
Start date:
Real Staffing
Republic of Ireland
Published at:
flag_no United Kingdom
Project ID:

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Duties include:

To manage validation of strategic computer systems such that they are validated in accordance with company and regulatory requirements and are maintained in accordance with those requirements.

* Planning and managing validation of high cost, complex, strategic systems using risk based approaches to ensure systems are fit for purpose, that significant risks are identified and mitigated, and that the approach and rigour of validation is in proportion to the risks the systems present to regulated business processes.

* Preparation and approval of validation documentation or management of the process (fulfilling the Quality Assurance role) in accordance with the relevant processes (e.g. Quality Management System)

* Validation planning for projects including project interaction with IT, software suppliers, and outsource companies.

* Project problem resolution/avoidance - this typically involves ongoing interaction with IT Managers/Directors, site Validation Managers and senior management of suppliers.

* Good knowledge of 24 CFR part 11, GAMP 5, Delta V, I.T systems.

* To train other members of staff within various departments in I.T systems

* Providing Compliance oversight and training to internal and external suppliers, e.g., IT teams outside GMS and globally sourced providers, as applicable

* Ability to work under minimal supervision; Assess priorities and work well under pressure in a fast paced environment

* 5 years experience within a Pharmaceutical environment (GMP and/or 21 CFR part 11)

This is an excellent opportunity with competitive hourly rates. If you are interested in this opportunity please contact Sarah Irvine on