QA Specialist

 

Who We Are

 

Founded in 1908, LEO Pharma is an independent, research based pharmaceutical company focused on improving the lives of people that live with dermatological and thrombotic conditions. Headquartered in Denmark, we employ 6,000 employees worldwide.

 

In 1987, LEO Pharma built a heparin purification plant at Little Island, Cork, which now employs 50 personnel. The LEO Pharma Group has invested heavily in the Cork site, which is one of two plants involved in the manufacture of anticoagulants.

 

At LEO Pharma Cork, we strive to create work environments that foster people management, development, engagement and collaboration, enabling us to build on LEO Pharma’s unique culture. Our people exhibit excellent teamwork and with a family like approach, are united in finding solutions. We provide our employees with the opportunity to increase the depth of their day to day responsibilities to enable flexible, cross functional, successful teams. At LEO Pharma Cork, we reward and recognise our people in a value adding way.

 

The Role

 

LEO Pharma Cork are currently recruiting a QA Specialist to join our team. This is a 12 month contract position, reporting to the Associate 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.

 

Requirements

We expect:

·      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.

 

LEO Pharma is an equal opportunities employer.

 

By sending your CV to LEO Pharma, you are consenting to the processing of your personal data, as outlined throughout our privacy statement. Please visit our website for more information. 

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