salary negotiable depending on experience

PLEASE NOTE, DUE TO THE URGENCY OF THIS VACANCY, OUR CLIENT IS UNABLE TO GO DOWN THE ROUTE OF WORK PERMITS, VISAS OR SPONSORSHIP.

IT IS THEREFORE ESSENTIAL THAT ALL CANDIDATES HAVE FULL AUTHORITY TO WORK IN IRELAND

Summary of Position with General Responsibilities:

Responsible for validation of all in-house systems as defined by business needs to ensure compliance with relevant international and corporate standards.

Ensure local software procedures are kept up to date with current process and remain compliant with Corporate and international regulatory standards.

The position may also include some development activity and the function will be expected to lend any support as deemed appropriate by ITS management.

Essential Job Functions:

Lead and execute computerised systems validation activities on site including defining the validation requirements and ensuring systems compliance to local bad corporate procedures, EU GMP Annex 11, 21 CFR Part 11, GAMP 5, along with the continuous regulatory expectations.

Validation of any new systems required by the business and any changes to existing systems.

Support validation activities for any new manufacturing equipment with embedded software.

Take part in risk analysis activities when an IT input is required.

Proactively coordinate computerised systems validation activities and act as a central point of contact for the site for computerised systems.

Validation to ensure the projects are delivered on schedule.

Review any software validation documents produced internally or by external contractors.

Provide software validation input to continuous improvement teams as required.

Support specialised project development activities associated with the computer environment.

Perform other tasks as required by quality management.

Additional Duties:

Review updates to software related corporate standards and applicable regulations and implement locally where applicable.

Basic Qualifications:

To perform this job successfully, an individual must be able to work effectively in a team environment that integrates technical and user expertise, as well as divisional and corporate team goals.

The team focus will be on strategic information delivery to provide a competitive advantage in the marketplace.

The team will provide this focus through the creation of companywide standards and user required systems.

Support issues such as system feasibility, system development, user training, policy generation, and documentation will be handled through team “Cross-Functional” participation.

Education and/or Experience:

Computer Science related qualification
Experience with computer software validation lifecycle and knowledge of relevant regulations and guidelines e.g. EU GMP Annex 11, 21 CFR Part 11, GAMP 5

Must have experience with drafting software validation documentation.

Programming experience would be an advantage – in particular, knowledge of SQL, ASP, Javascript, and HTML.

Experience of working in a regulated medical device industry would be desirable, not relevant any more as this is Cognizant’s responsibility

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