Senior QA Officer

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

• 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
  
  Degree qualified (Scientific) or significant experience in the Pharmaceutical industry in a similar role
• Sterile manufacturing experience preferable
• Computer literate
• Problem solving skills