Process Flow 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 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 Process Flow Specialist (PFS) to join our team. This is a 2 year contract position which will work on a shift cycle reporting to the Operations Manager and will be responsible for removing all blockages to making the process flow. The PFS role is to make the process and the equipment flow at the same speed. This means that there is a real integration of process and equipment and the PFS will coordinate all activities.
- Co-ordinator of operator activities on shift to ensure efficient operation of production processes.
- Co-ordinator of all process and equipment schedules in the process and tank farm areas.
- Reviewing BMRs, recipes and process related documentation. Support real time batch record review.
- Drive productivity initiatives focusing on yield improvement, minimizing cost and maintaining process consistency.
- Generate & Evaluate manufacturing metrics and performance indicators to proactively identify risks, out-of-trend and quality issues.
- Investigate deviations with responsibility to interface with TAS, and Quality approvers. Focus on high quality investigations, meaningful corrective actions, and reducing the deviation generation rate. As part of the deviation management role, present and defend investigations during regulatory inspections, as required.
- Originate and manage the change controls for processes.
- Responsible for the update and maintenance of GMP documentation for the manufacturing process –BMRs, SOPs, and WIs. Ensure that documentation complies to GMP and EHS regulations.
- The PFS is responsible for the training program for operators. The requirement is to ensure that there is a cross training program in place to develop operators, to provide full cross training cover for all processes and to allow for altered plans when abnormal variation occurs in the process.
- Participate in Regulatory Authority GMP inspections and audits.
- The PFS is responsible for CAPAs and RA’s assigned to the production process in the LQT, eQuality and mai® systems. The timely closure of these actions has high priority for the role.
- Regular cross functional interactions on site in Cork and with the Esbjerg operations team.
- Third level degree qualified in a scientific, chemical, engineering or equivalent discipline.
- 5 years’ experience in a manufacturing environment within the pharmaceutical industry.
- Qualification or experience of biotechnology or bioprocessing is a plus.
- Dependability - being reliable, responsible, and fulfilling obligations.
- Attention to Detail - being careful about detail and thorough in completing work tasks.
- Cooperation - being pleasant with others on the job and displaying a good-natured, cooperative attitude.
- Initiative - a willingness to take on responsibilities and challenges.
- Ability to work in a matrix organization to leverage expertise from other functions and departments.
- Ability to work quickly, proactively and independently without close supervision.
- Self-disciplined and self-motivated and have the ability to comprehend the extensive production operations and schedules.
- Strong verbal and written communication skills.
- Strong Excel, Word and PowerPoint skills.
- Ability to navigate in documentation management systems, such as, eQuality, LQT, Mai® etc.
- Team orientation with the ability to influence others.
- Flexibility essential.
- Strong influence and persuasion skills, bias for action, execution and delivering business impact and results
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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