Senior Quality Assurance Officer

2 weeks ago


Runcorn, United Kingdom Fresenius Kabi Limited Full time

Overview:
Are you a Quality Assurance Officer?

Reporting to the Quality Assurance Manager, you will be supporting the Head of Quality Assurance and the Quality Assurance & Compliance Manager in the development, implementation, maintenance and continuous improvement of the QMS This role will be a full-time role, 37.5 hours per week, Monday-Friday and based in Runcorn.

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company's products and services are used to help care for critically and chronically ill patients.

With a corporate philosophy of 'caring for life', the company's goal is to improve the patient's quality of life.

Our product portfolio included a comprehensive range of IV generic drugs, infusion therapies and clinical nutrition products as well as the medical devices for administering these products.

**Responsibilities**:

- Providing support to the Quality Assurance and Compliance Officers and assisting in their personnel development within the Quality department
- Developing, implementing, maintaining and continuously improving the local Quality Management System (QMS) in line with the Fresenius Kabi QMS
- Performing audits to support the identification, actioning and close out of non-compliance issues and to support continuous improvement of the QMS
- Leading and supporting successful back room teams
- Generating new standard operating procedures and reviewing existing standard operating procedures to ensure effective implementation of quality standards in accordance with GMP
- Investigating the root cause(s) of non-conformances, identifying and ensuring implementation of robust corrective / preventive actions to reduce non-conformances
- Checking the effectiveness of corrective and preventive actions, and action as appropriate
- 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
- Preparing and completing product quality reviews to ensure compliance with regulatory requirements and to identify areas for improvement
- Delegate for Quality Assurance manager as and when required

Qualifications:

- Degree Qualified (Scientific) or 3 - 5 years’ experience in the pharmaceutical industry in a similar role
- Sterile Manufacturing experience preferable
- Computer literate
- Problem Solving Skills



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