Senior QA Officer

at  Fresenius Kabi Limited

Overview:
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.
This role will be 37.5 hours per week Monday-Friday. The working hours are 9am - 5pm and it will be based in Runcorn.

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

• 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 require