Description
QA CSV Engineer - 12 Month Hourly Rate Contract (Cork)Key Activities
- Develop a process for and performing validation of computer and/or automation systems compliance current Good Manufacturing Practices (cGMPs) and other regulatory requirements such as Annex 11, GAMP and 21 CFR Part 11.
- Support activities include, but are not limited to, SOP creation, documentation review and approval including change controls, assessment plans, risk assessment reports, compliance plans, user requirements, system and user acceptance testing protocols, traceability matrix, error reports/defect report forms and summary reports.
- Compile and analyse validation data and makes recommendations for changes and/or improvements.
- Participate on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups. * Contributes directly to the completion of projects through the management of assigned contract personnel, development and execution of validation change control documents, and development and review of protocols, reports and data tables generated by peers and contract personnel.
- Prepare summaries of validation testing for regulatory submissions and presents validations to regulatory agencies.
- Resolves computer systems validation issues of moderate scope with limited direct supervision.
Educational/Professional Details
- Bachelors' degree in a technical, scientific or related field is preferred.
- Minimum 5 years of related industry experience
- Minimum 3 years of experience in CSV system development life cycle is required.
- Validation experience with ERP, MES, LIMS, and Quality Systems is preferred.
- Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 is required.
- Strong knowledge of system development life cycle is required.
- Knowledge/familiarity with U.S. and Global regulatory registration of drug products is preferred.
If you would like to hear more about the position feel free to email or call John Lennon on for a confidential chat.