Hannah Milward at CK Science is recruiting for three Senior Business Unit Specialists on a contract basis for the duration of 12 months initially. The Business Unit Manager will be based in Cork working for a global healthcare organisation.
As Senior Business Unit Specialist you will be responsible for providing technical support to the business unit in ensuring efficient manufacturing while ensuring compliance with GMP, EHS standards at all times.
Further responsibilities of this Senior Business Unit Manager Specialist include:
- Development of new and revised manufacturing Master Batch Books.
- Management of deviations (including customer complaints, EHS incidents, Quality Deviations etc) to ensure timely investigation, root cause analysis and implementation of corrective and preventive actions.
- Preparation of Process & Cleaning Validation protocols and reports as required by the business unit and coordination with other business unit partners to ensure all other validation requirements are met in line with the Site Validation Master Plan (e.g. analytical validation)
- Identification of opportunities for improvement within the manufacturing process through trend analysis and continuous review of all operations (e.g. completion of Self Inspections/ Internal Audits) as well as liaising with production personnel to identify opportunities for improvement
- Generation and justification of Change Requests in order to ensure that opportunities for improvement are implemented in a safe and cGMP compliant manner
- Where changes are significant the business unit specialist is required to project manage these changes to ensure that personnel from all departments complete project tasks in to support the overall change implementation
- Development of and subsequent reporting on metrics relating to the performance of the manufacturing processes.
- Development and data collection for scorecards, dashboard and data for management review.
- Degree or equivalent qualification in engineering of science experience in the industry.
- Computer proficiency and technical writing is a requirement and experience of equipment gained in production or engineering role would be a significant advantage.
- Structured project management experience would be an advantage.
How to apply:
For more information or to apply for the position please contact Hannah Milward on 0114 2839956 or email firstname.lastname@example.org.