Senior QA Officer
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.
The Role
Are you a QA Officer and looking for somewhere you can advance in your career, this could be the opportunity for you! We are looking for a Senior QA Officer to join our Quality department. You will be an integral part in providing each individual patient with customised Parenteral Nutrition, whether they are critically or chronically ill. The role is full-time, 37.5 hours per week, Monday - Friday and is based in Runcorn, Cheshire.
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
- Supporting with supplier quality management and document management processes
- Delivering GMP or other training to managers and staff to support improved application of GMP standards as appropriate
- Delegate for the Quality Assurance Manager as and when required
Qualifications
- Degree qualified (Scientific) or significant experience in the Pharmaceutical industry in a similar role
- Sterile manufacturing experience preferable
- Computer literate
- Problem solving skills
Benefits
- Contributory Pension Scheme (rises with service)
- Role specific tailored training and development plan
- Life Insurance (4 x salary, death in service)
- 25 days holiday (rises to 27 after 5 years service) and ability to buy/sell holidays
- Maternity, Paternity and Adoption Leave
- Professional fees paid
- Bike to work scheme
- Long Service Awards
- Employee Assistance Programme
- Free onsite parking and subsidised canteen
- Blue Light Card
- Company funded family days out
We are proud to foster a workplace free from discrimination. Diversity of experience, perspectives, and background create a better work environment and better products. Whatever your identity, we will give your application fair consideration.
