Computer Systems Validation Engineer
Experienced CSV Engineer required to for large & growing Pharma Client based in Dublin.
Role is responsible for implementation of the Site Validation Policy and compliance with regulations and current industry standards.
Key Responsibility:
- Preparation, review and/or approval of both laboratory and manufacturing based computerised system validation lifecycle documentation.
- Assessment of both laboratory and manufacturing systems against Data Integrity, EU Annex 11 and 21 CFR Part 11 requirements.
- Compliance with all site GMP and EHS policies and procedures
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- Preparation of action or remediation plans for each system or site wide systems as deemed necessary.
- Lead implementation of actions identified in remediation plans.
- Working with other deparments during the gap analysis, action identification and implementation stage.
- Review of existing system qualification documentation to assess the overall level of compliance.
- Preparation, execution and/or approval of system qualification documentation.
- Preparation, execution and/or approval of summary reports.
- Generate system data process flow maps.
- Identification of system source data and meta data.
- Preparation, review and/or approval of system specific or site policies and procedures where required.
- Provide validation oversight on automation systems and support for the installation of new control systems on site.
- Proactively highlight issues around compliance.
- Perform periodic reviews of systems.
Experience Required
- BSc Engineering, Computer Science or related
- Excellent communication experience
- 3 years CSV experience in regulated environment
For more information contact Peter Mulvihill on p.mulvihill@masonalexander.ie or 01 685 4414.
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