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Karen Shiel
Life Science

+353 1 5079256
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Operational Excellence & API Support Leader

Reference:KS/AMRE-648346 Location: Sligo
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Our client is a global Pharmaceutical organisation with manufacturing sites throughout Ireland. They are currently sourcing anAPI Support and Operational Excellence Leaderto join their high performing team in Sligo. In this role, the successful candidate will lead the API Days manufacturing shift and also manage the operational excellentfunction within API manufacturing. The company’s high containment facility was established in 2002 and has dedicated capabilities for potent active pharmaceutical ingredient and drug product manufacturing. This site recently underwent a significant €85 million expansion that doubled its footprint and provided additional capability to support our clients’ new product introductions so it is an exciting time to join the team.


  • Supervision and execution of pharmaceutical processing activities in the API building, (milling and dispensing) and support locations, to meet clearly stated operating objectives. Daily reporting on the status of all operations and support activities.
  • Responsible for leading theoperations excellence program in API and delivering on the Continuous Improvement Plan for the area.
  • Team leadership, motivation and direction to maximise the effectiveness of their manufacturing team.
  • Responsible for verification and update of manufacturing control system transactions accurately and in a timely fashion.
  • Act as key point of technical contact for API Business Unit.
  • Communicate the departmental goals, to provide cost effective products as part of the Class A supply chain system.
  • Liaise with Supply chain & program management group to ensure effective planning, scheduling and execution of commercial and NPI clinical manufacturing.
  • Resolves operations/project issues by working with team members, project customers, and others as appropriate.
  • Ensure the execution of pharmaceutical processing activities in the API building and support locations, to meet clearly stated operating objectives.
  • Drive safety improvements and initiatives across the operation.
  • Ensure successfully review, amendment and implementation of changes to SOPs and managing CAPAs.
  • Promote a culture of perfect performance and Enhanced Right first time within their team.
  • Liaise with the relevant departments & customers in the introduction and execution of NPIs Projects.
  • Work closely with the API leadership team to ensure interdepartmental activities are planned and executed safely.
  • Develop direct reports by securing appropriate training, assigning progressively challenging tasks and managing mid-year and annual reviews.
  • Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
  • Assist in the identification, implementation and execution of key API and Site Strategies.
  • Responsible for all resource capacity planning for API business

Education & Experience

  • Relevant degree in science or engineering
  • A minimum of 5 years’ experience in batch processing, automation, commissioning and validation in an FDA/HPRA regulated industry. Detailed knowledge of cGMP and regulatory requirements
  • Background as an Operational Excellence Driver with proved track record in driving lean manufacturing practises.
  • Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality requirements.
  • Previous exposure to supply chain & schedule delivery in a manufacturing environment.
  • A minimum of 1 year previous experience of supervising a team environment with active participation in proactive improvement programs.
  • Required to travel - 5 % of the Time

If you would like further Information you can contact the recruiter directly:

Karen Shiel | Tel: +353 (0) 1 5079256