Quality Assurance Officer

2 weeks ago

Hull, United Kingdom Kenton Black Science & Engineering Full time

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
- 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

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