LEO Pharma Cork are currently recruiting a Quality Specialist to join our team. This is a contract position, reporting to the Senior Manager, Quality, Operations Cork, and will have responsibility for cGMP compliance support of API manufacturing.

 Responsibilities

• Supporting the full range of daily compliance activities on the Cork site.
• Day to day compliance activities including: raw material and intermediate release, approval of Change Control, Deviations, Change Actions and CAPA, and supporting the QC Laboratories, Maintenance and Operations departments.
• Collaboration with other functions both globally and locally on Quality Improvement Initiatives.
• Review and approval of Standard Operating Procedures, Test Methods and Protocols.
• Participating in timely execution of KPI for the Quality department.
• Participating in continuing professional development to maintain awareness in current and new regulations and ensuring new regulations are implemented.

• you have a minimum qualification of a Bachelor level degree in Chemistry, Microbiology or a related discipline.
• you are an all-round Quality compliance person with at least 5 years’ experience within the pharmaceutical industry.
• you are skilled in the use of a variety of problem-solving techniques (A3/DMAIC) and also in the execution of Risk Assessment.
• LEAN and Six Sigma philosophy are embedded in your day to day working.
• you enjoy working close to your stakeholders and have a hands-on operational approach to Quality.
• you are a good communicator and when collaborating on a given task you contribute with a positive and constructive attitude.
• you can work un-assisted in an organised manner and have good personal drive.