Role & Responsibilities:
This role will involve reasonability for the following;
- To scope out key IS design/development projects based on Function demands and alignment with ERP strategy.
- To co-ordinate/make essential program changes to the GMIL Database System in line with specified business demands.
- To manage the integration of new systems (off the shelf/custom designed ) with the GMIL database System.
- To oversee the maintenance of the GMIL Database System and provide support to users throughout GMIL.
- To evaluate off-the-shelf ERP systems and select an appropriate ERP system that best fits GMIL’s future business position.
- To enable full system regulatory compliance based on system software regulations ( ref: FDA, BSI standards ).
- To project-manage systems design/development activities ( new application introductions etc ) to agreed project timelines
- To maximize systems, support resources through efficient work distribution, co-ordination and communications.
- To broaden communications with systems development management within Goodman/Nipro corporation.
- To interface with the appropriate hardware support providers to troubleshoot and resolve systems issues.
- To develop and document training manuals for IS systems. To deliver training to appropriate personnel when required.
- To lead the GMIL IS team effectively and provide essential people management support where required.
- To co-ordinate, in conjunction with validation engineering, the validation of new applications to satisfy regulatory standards.
Knowledge and Skills Required:
- Demonstrable Knowledge of medical device quality systems and ISO13485.
- An ability in number orientation (abilities in Mathematics; Accounting; statistics; and/or Finance)
- Strong computer programming Skills in Visual Basic for Applications (VBA) and T-SQL (Sql Server).
- Excellent Computer Skills (word, excel, PowerPoint and Access).
- Excellent communication (both verbal and written) & interpersonal skills.
Qualification and Education requirements:
- Requires a Level 8 or higher degree in an IT/IS design and Development
- 10 years’ experience within the medical device industry
- 8 years relevant experience in design/development and implementation of impactful ERP Systems.
- Recent experience with FDA GMP requirements is highly desirable.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Emma on 083 0093553 or alternatively send an up to date CV emma.knight@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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