The Quality Assurance Analyst is responsible for supporting daily quality operations associated with software development and delivery, and supporting the implementation and management of all aspects of the Quality Management System (QMS) within the organisation.
The successful candidate will work collaboratively with software developers, IT staff, account managers, other QA personnel and business stakeholders to ensure that quality and compliance are the cornerstone of all aspects of the company’s operations, and that all customer, business and regulatory requirements are met to the highest degree of satisfaction.
Primary Responsibilities Include
- 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, ensuring that projects are audit-ready at all times. Maintain QA dashboard and metrics.
- Regulatory and customer audit support; ensuring audit readiness at all times.
- Supporting external vendor audits.
- Assessment of compliance systems on ongoing basis to identify opportunities for process improvement.
- Reporting to management on the conformance/compliance state of our QMS based on internal audits.
- Supporting the customer complaints process
- Tracking and monitoring the implementation of corrective actions to provide assurance that deficiencies have been addressed.
- Provision of training on quality systems & methodologies to company personnel.
- Advising relevant personnel on the status of investigations and associated corrective actions and commitments, as appropriate.
- Review and approval of qualification/validation documentation
- Degree or higher in a science, engineering, IT or similar discipline.
Skills and Experience
- 2 years+ experience working in a Quality Systems or Quality Assurance related role.
- Understanding of ISO9001:2015 requirements and/or requirements for systems qualification in a regulated environment.
- Experience in change control, risk analysis, root cause investigation, complaint handling, non-conformances, corrective actions, etc.
- Effective writing and communication skills.
- A passion for quality in a leading-edge technology based organisation.
- Ability to work well independently or on a team.
- Work within regulated life sciences or IT industries a preference.
- Proven knowledge and understanding of IT / Life Sciences industry regulations, including FDA and GxP requirements.
- Experience of participating in customer / vendor audits.
- Understanding of ISO27001 requirements and/or IT and data security.
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