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 5,000 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 Heparin ® API and innohep ® API which are high earning brands for LEO Pharma.
At LEO Pharma Cork, our vision is to be the preferred partner in Cancer Associated Thrombosis care management and to achieve this, we are focused on our mission of advancing the care of patients with Thrombosis. At LEO Cork, we know that the work we do ultimately saves lives.
At LEO 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 Cork, we reward and recognise our people in a value adding way.
LEO Pharma Cork are currently recruiting a Validation Specialist to join our team. This is a 2 year contract position reporting to the Project Manager.
LEO Pharma have shown their commitment to the future of innohep® with significant investment being secured for the LEO Cork site. This investment will deliver a new state of the art facility for innohep® API wet processing. The successful candidate will play a key role in delivering this project for the innohep® value stream and additionally supporting other projects from time to time.
This person will bring current understanding of wet processing to enable the design of the new facility. As Validation Specialist you will be the primary validation representative responsible for the project. You will be trusted to lead and advise the validation of new facility, utilities, equipment and processes as part of the project team – and you will do it via a constructive dialogue founded within a pragmatic understanding of the business’ needs.
- Lead the Qualification and Validation support on the Wet Processing project team to ensure compliance with the requirements of Code of Federal Regulations 21 CFR Parts 210, 211 and Part 11, EudraLex Rules Governing Medicinal Products in the European Community Volume 4 and Annex 1-18, ICH Q7A and Company policies and procedures.
- To lead the validation of new facility, utilities, equipment and processes and liaise with the project team on qualification & validation scheduling and reports to ensure a good design basis is established for all validation studies.
- Preparation, and reviews of VMP/DQ/FQ/IQ/OQ/PQ/PV/CV protocols/reports and associated deviations for equipment, facility, utility, process & computerised systems.
- Preparation and reviews of FAT/FS/URS/SDS/HDS documents and reports to ensure a good design basis is established for all validations
- Implementation of Cleaning Validation program for the project
- Minimum qualification of a Bachelor Degree in a scientific/technical discipline required
- 5 years’ experience working with validation and qualification projects in the pharma industry.
- Experience in relevant regulatory requirements
- Experience working across a Global business a distinct advantage
- Skilled in the execution of Risk Assessment and in the use of a variety of problem solving techniques
- Experience in projects, audits & inspections as Validation SME
- LEAN and Six Sigma philosophy are embedded in your day to day working
- Enjoy working closely with your stakeholders and have a hands-on operational approach to Validation
- A good communicator and when collaborating on a given task you contribute with a positive and constructive attitude
- Work independently with strong personal drive
- Strong attention to detail and organisational skills
- Have the ability to critically assess issues and devise and execute appropriate solutions using problem solving techniques in a decisive manner
- Strong business mindset
- Travel may be required as part of the role to represent Global Quality on elements of project implementation.
If you think you have what it takes to join our team and Help SARAH, we would love to hear from you.
LEO Pharma is an equal opportunities employer.
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