Senior QA Analyst – Limerick
We are looking for a Senior QA Analyst who will get to work with and learn some of the latest cutting edge technologies, in an a growing business that’s having a transforming impact within the global Validation Life Cycle Management.
The Company
My client based in East / Dublin side of Limerick is a Pharmaceutical software product based company who leverage the latest cutting edge technologies to deliver world class solutions for their clients . They cultivate a self-organised, multi-disciplinary, full stack development team. Primarily working in JavaScript and C# on enterprise level web applications, moving towards a SaaS model, for regulated industry and now they are looking to hire a Senior QA Analyst.
Key points
• Market leader in their sector
• Work with cutting edge tech
• Expanding massively over next two years
• Pension, Healthcare, Flexi-Time, Gym subsidised
The Role
As a Senior QA Analyst you will work in the implementation and continuous improvement of Quality Management System (QMS)
Generation of policies, procedures and guidelines as part of the QMS
Internal QMS audits and input into management reviews
Ensuring that all project documentation is delivered into the QMS
Approval and management of project documentation and other project deliverables
Regulatory and customer audit support; ensuring audit readiness at all times
Tracking and monitoring the implementation of corrective actions to provide assurance that deficiencies have been corrected
Review and approval of qualification/validation documentation
Skills
Diploma/Degree or higher in a science, engineering, IT or similar discipline
Senior QA Analyst with 5 years experience
Understanding of ISO9001 requirements and/or requirements for Systems Qualification in a regulated environment
Experience in Change Control, Risk Analysis, Root Cause Investigation, Complaint Handling, CAPA, Non-conformances etc
Preferred candidates would also meet the following criteria
Proven knowledge and understanding of IT / Life Sciences industry regulations including FDA and GxP requirements
Experience of participating in customer audits
Experience of participating in vendor audits
Plus
Senior QA Analyst with an understanding of the new ISO9001:2015 requirements
Understanding of ISO27001 requirements and/or IT and data security
This is a solid opportunity for a Senior QA Analyst so call John today on 01 2449516 and email the latest CV to John(a)solasconsulting.ie
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