- Reference: CJ44562
- Job Type: Permanent
- Location: Cork, Cork City, Munster
- Category: Information Technology
- Site Subject Matter Expert (SME) person and co-ordinator for computer validation/test activities.
- Site SME for computer software validation (cave) during internal and external audits
- Ensure regulatory compliance with internal and external validation regulations, particularly with company corporate cave requirements
- To co-ordinate activities relating to the implementation and maintenance of the Quality System in order to comply with Corporate, EC, FDA and Canadian requirements.
- Drive continuous improvement initiatives within the Quality systems department.
- Ensure relevant procedures are kept up to date and maintained to the relevant company standards and to industry best practice.
- Provide guidance and assistance with the preparation of validation protocols, test protocols, software design specifications, and associated documentation for all cave applications.
- Participates on project teams to develop clear specifications, evaluate feasibility of concepts, and provide estimates for System designs.
- Determines Project schedules for remediation of legacy systems and works with cross functional teams to ensure adherence.
- Provides guidance, training and direction on cave to staff across various functions. Provide software validation/compliance/part 11 leadership.
- Take part in vendor audits of critical equipment vendors.
Qualifications & Experience
- The Diploma in Information Technology/Computer Science or equivalent is desirable. A degree is a distinct advantage.
- Preferable 2.5 years’ experience in a similar role, preferably in a large multinational company.
- Demonstrate strong communication and problem solving skills. Customer focused approach.
- Flexibility in working off- peak hours as support or project activities demand.
- Proven IS background in some of the following: Net, VB, SQL, Web Development, Relational databases.
For a confidential discussion and more information on the role, please contact Karen Collins on 021 4911064 or email email@example.com
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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