Description
Duration: 12 months
Work Location: Cork, Ireland
Detailed JD is below -
BSc. Degree (Technology related preferred) with 5+ years technology or information systems experience
Strong knowledge of business processes across manufacturing, supply chain & quality
Experience with Computer Systems Validation preferred
Knowledge of 21 CFR Part 11 and EU Annex 11 regulations preferred
Independent problems solving skills
Skills & Experience Required
Good verbal and written communication skills.
Good organizational skills.
Must have good interpersonal skills. Position will involve a lot of interdepartmental interaction and coordination.
Must possess a thorough understanding of GxP, in addition to FDA and International requirements for computer validation and Part 11/Annex 11 requirements.
Must possess a thorough understanding of current industry guidance, including GAMP 5
Must have direct experience with computer validation and determining computer validation approach, including enterprise platforms systems as well as custom software projects.
Skills & Experience Required
Develop and executes all validation project deliverables
Capable of owning issues and driving them to resolution
Capable of reviewing validation protocols, Test scripts and traceability Matrix
Must possess a thorough understanding of GxP, in addition to FDA and International requirements for computer validation and Part 11/Annex 11 requirements.
Must possess a thorough understanding of current industry guidance, including GAMP 5
Must have direct experience with computer validation and determining computer validation approach, including enterprise platforms systems as well as custom software projects.
Good verbal and written communication skills.
Good organizational skills.
Must have good interpersonal skills. Position will involve a lot of interdepartmental interaction and coordination.