Lotus Technical Services is a leading solutions provider offering a complete range of automation and technical services specifically designed to enhance productivity and efficiency, and to maximise the value of our customer's core business. We are currently recruiting a Software Tester based in Limerick.
· Prioritize qualification activities in line with the project schedules and business needs.
· Develop Validation Documentation to support new process/product introductions and existing business continuity and process improvement requirements
· Execute qualification protocols as required including risk assessments and regulatory reviews.
· Resolve and assist in the closure of deviations initiated during qualification execution.
· Complete 21 CFR Part 11 and Annex 11 Assessments - experience of CFR Part 11 & CSV would be an advantage but not essential.
· Conduct validation activities in compliance with US and EU regulations, global procedures and EHS requirements.
· Implementation and co-ordination of the change control process, review change controls for validation impact, promotes timely approval of all supporting documentation.
· Generate SOP’s / other documentation as applicable.
· Validation representative at daily project management meetings, weekly change control and team meetings.
· Work with all departments in ensuring operational effectiveness and developing product Quality for business continuity and process / product introductions.
· Identification and root cause analysis of potential bugs.
· Participate in Troubleshooting.
· Manage defects through a defect tracking system.
· Work with the various departments / groups in development and execution of validation activities associated with new system or System upgrades.
· Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project.
· Proven track record in development / execution of Validation programs in areas of Systems
· Run / Manage complaint investigation and resolution of same.
· The successful candidate will have a minimum of 3-4 years testing experience in an Oracle/ Web based environment/ Microsoft SQL, preferably in the healthcare industry.
· Strong knowledge of CSV/GAMP, 21CFR Part 11, Annex 11, Project Life Cycle and cGMP Regulations,
· Working knowledge of development and test life cycles.
· Firm sense of accountability, ownership for end-to-end project lifecycle and sound knowledge of project management.
· Good knowledge of statistical techniques in the use of problem solving / data analysis.
· Outstanding verbal and written communication and presenting skills with the ability to interact with technical and non-technical groups.
Lotus Technical Services is an Equal Opportunities Employer