Position Details

REPORT TO
Engineering Manager 

JOB DESCRIPTION
This position uses policies and procedures to validate/qualify and maintain computer systems, including process automation systems, information Systems applications/infrastructure, and enterprise systems (e.g. ERP, Document Management Systems). Plans, implements, coordinates, and participates in a EU GMP compliant validation process for quality information technology and automation systems which require formal validation documentation under appropriate regulatory requirements and company manufacturing standards. 

RESPONSIBILITIES:
•    Prepares/reviews validation documentation related to projects/change controls including risk assessments, traceability matrices, and validation reports
•    Executes validation activities and protocols on affected systems
•    Manages computer system /automation related change controls and other compliance related tasks e.g. non-conformances.
•    Leads and participates in the creation and review of existing and new CSV procedures and polices.
•    Analyses the results of testing and determines the acceptability of results against predetermined criteria.
•    Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
•    Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance with EU GMP Annex requirements.
•    Auditing of internal projects against internal validation policies and procedures
•    Managing and co-ordinating the review and approval of specifications associated with Computerised Systems
•    Coordinates with internal Global Departments or outside contractors/vendors to complete validation tasks.
•    Reviewing and approving vendor validation documentation
•    Participates in regulatory audits and communicates company’s computer validation policies.
•    Supports the Quality Approval of Vendors and Suppliers of GxP computer systems 
•    Assesses company’s computer systems and identifies / addresses any potential 21CFR Part 11 or EU Annex 11 gaps.
•    Manages projects and prepares status reports using Microsoft project and other communication tools.
•    Supports local IT and Global IT on maintenance and testing of physical network infrastructure and security 

Qualifications, Experience and Skills:
•    Requires third level degree in Science, Engineering or Computer Science with 5+ years of related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation; will substitute relevant experience for education. 
•    Experience with Enterprise Systems (ERP) in a GMP production environment essential.
•    Experience of maintenance of GxP Computerised Systems in compliance within annex 11 requirements 
•    Industry knowledge of EU GMP and Annex 11 Computerized System Validation requirements
•    Familiar with the GAMP5 guidelines
•    Experience in Generation and Execution of CSV Protocols and Summary Reports
•    Excellent communication skills, including ability to advise and influence
•    Excellent attention to detail
•    Proficient in Microsoft Office Suite, specifically Word, Excel and PowerPoint