Do you have a passion for driving a culture of quality excellence? Are you motivated individual with who is looking for a challenging yet fulfilling position?

My client is looking for a Quality Assurance Officer to join a small team, reporting to the Quality Assurance Manager, you will support the QA Manager in the management of the QMS to the required regulatory standards.

This is a hybrid position; office and home working options.

The Role:

• Developing, implementing, maintaining, and continuously improving the Quality Management System (QMS)
• Performing internal and external audits to support the identification, actioning and close out of non-compliance issues and to support continuous improvement of the QMS
• Generating new standard operating procedures and reviewing existing standard operating procedures to ensure effective implementation of quality standards in accordance with GMP
• Perform investigations on non-conformances/deviations/OOS, review information and draw conclusions in support of CAPAs, customer complaints etc.
• Investigating the root cause(s) of non-conformances, identifying, and ensuring implementation of robust corrective / preventive actions to reduce non-conformances
• Collating, reviewing, and interpreting data from the QMS process
• Performing trend analysis of data and generate trend analysis reports
• Conducting risk assessments and gap analysis of the current quality systems and generating appropriate action plans

The candidate:

• A minimum of a bachelor’s degree or equivalent in a Chemistry or Biology, or related discipline
• Experience of working in a quality assurance or quality control related function
• Experience of working in a lab based regulated environment with exposure to quality systems
• Experience of performing investigations on non-conformances/deviations/OOS and root cause analysis
• Experience of auditing would be desirable
• Experience within the Pharmaceutical and/or Medical Device industries