IT QA Analyst

New Opportunity

Position Summary

Kneat Solutions is looking to hire an IT QA Analyst to work as part of our Quality Assurance team. This is an IT Quality Assurance role largely responsible for the governance of our Kneat SaaS infrastructure and cloud-based applications, governance of customer on-site installation projects and for IT Security both in-house and in the cloud.

Candidates will work collaboratively with IT staff, Account Managers, Software Developers and business stakeholders to ensure that Quality and Compliance are the cornerstones of Kneatā€™s installations on-site and in the cloud and that data security and compliance are assured for our customers.

 

Primary Responsibilities Include

  • Contributing to the implementation and continuous improvement of the Quality Management System (QMS).
  • Generation and implementation of policies, procedures and guidelines for our Information Security
  • Management System (ISMS) in accordance with ISO27001.
  • Assurance of customer data confidentiality, integrity and availability (CIA).
  • Review, approval and management of IT related project documentation and other project deliverables.
  • Ensuring that all IT related documentation is delivered into the QMS.
  • Internal audits and input into management reviews.
  • Regulatory and customer audit support; ensuring audit readiness at all times.
  • Ensuring that the Kneat Cloud and internal IT systems are audit-ready at all times.
  • Conduct external vendor audits.
  • Assessment of compliance systems on ongoing basis to identify opportunities for process improvement.
  • Provision of training in compliance systems / methodologies to company personnel.
  • Assisting in reporting to Management on the state of compliance based on internal audits.

 

Skills and Experience

  • 5 years+ experience working with IT Systems in a quality driven environment.
  • Understanding of ISO27001 requirements and/or IT Security implementations.
  • Understanding of ISO9001 requirements and/or requirements for Systems Qualification in a regulated environment.
  • Knowledge and understanding of IT systems and data security.
  • A passion for quality in a leading-edge software development and IT support organisation.
  • Ability to work well independently or on a team.

 

Qualifications

  • Diploma/Degree or higher in a science, engineering, IT or similar discipline.

 

Desirable Qualities

  • Experience in an IT QA role.
  • Worked to ISO9001 requirements. Work within regulated Life Sciences or IT industries a preference.
  • Worked to ISO27001 requirements.Proven knowledge and understanding of IT / Life Sciences industry regulations including FDA and GxP requirements.
  • Experience in Change Control, Risk Analysis, Root Cause Investigation, Complaint Handling, CAPA, Non-conformances etc.
  • Experience with the following would be beneficial.
  • Microsoft server technologies, including IIS and SQL Server.
  • Server Virtualisation.
  • Amazon Web Services.

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