Job Description

Key requirements

Your duties will include:

• Working with one or more project or operations teams to oversee compliance with the company's QMS, especially the planning and delivery of validation records.

• Critical review of validation evidence and documentation to ensure this meets company and customer standards.

• Preparing and delivering staff QMS and ISMS training.

• Conducting and reporting on regular internal audits of QMS and ISMS compliance.

• Conducting and reporting on CAPA investigations and root cause analysis.

• Monitoring and following up implementation of CAPA and audit actions.

• Assisting in document management activities: including preparation, formatting, reviewing, approvals, distribution and archiving.

• Assisting the Quality Manager in developing and evolving the QMS and ISMS to ensure it is relevant and fit-for-purpose.

• Identifying areas where processes can be optimized or improved; coordinating approved improvement initiatives.

• Collecting and reporting on quality metrics for monthly reports.

• Assist in conducting supplier quality audits.

• Communicating with customers and suppliers on validation evidence, corrective actions or other quality management activities as appropriate.

Personal attributes

You will:

• Be enthusiastic and tenacious

• Be analytically-mind, with the ability to logically analyze root causes, impacts and risks.

• Have a questioning mindset, with a desire to improve processes.

• Not be afraid to question or reject deliverables where these do not meet company or customer standards.

• Be able to understand and clearly communicate QMS processes, rationale and requirements to other staff.

• Have excellent interpersonal skills.

• Have the ability to establish professional relationship with your colleagues

Experience

You will:

• Have at least four years' experience in a commercial software development or IT service and operations organization.

• Have at least three years' experience in a quality and information security management role within an ISO 9001 and ISO 27001-certified organization, including conducting audits, staff training and root cause analysis of non-conformities.

• Have attended and passed internal (or lead) auditor training from an IRCA-approved training provider.

• Be technically literate with solid knowledge of the software development life cycle, IT service and operations.

• Be able to demonstrate ITIL experience (strongly preferred).

• Be able to demonstrate knowledge of GDPR compliance (strongly preferred)

• Have good written English and experience of report preparation, proof-reading and formatting.

• Be degree educated within a Business or IT related field.

Required Knowledge, Skills, and Abilities