Our client, a leading pharmaceutical company based in Limerick currently has an opportunity for an Inspection Management Specialist. This is a full time, permanent position offering an excellent salary and benefits package.
Essential duties and responsibilities include but are not limited to the following:
- Assist with compiling information and requests in support of site registration requests, regulatory inspections and partner audit operations. To include determining the content required to fill those requests.
- Maintain action lists and follow up on the completion of actions in support of site inspection readiness. Including review of actions to determine if they are sufficient to close items.
- Prepare action reports for IMT and site personnel including but not limited to weekly status updates, metrics, operation reports.
- Develop good communication and working relationships with site functional areas to include department leaders and line managers.
- Maintain team documents and records ensuring content is accurate and up to date supporting inspection readiness. Manage documents both written and electronic and those stored on the IMT SharePoint.
- Support logistics during inspection operations in assigned inspection role.
- Support and coordinate internal meetings and or meetings with site departments
- Schedule and organize meetings
- Take meeting minutes
- Follow up on assigned actions with other groups
- Perform updates of inspection readiness documentation (i.e. opening presentation or inspection binders).
- Lead or support additional projects and activities as assigned by supervisor
- Seeks to continuously improve process and systems.
Knowledge and Skills:
- Must be quality minded, action oriented and highly organized
- Must display strong interpersonal communication skills and the ability to interact with team members with tact and diplomacy
- Must have the ability to handle multiple priorities and tasks with time management skills and prioritizing tasks for completion.
- Computer skills needed; proficiency in MS Office (Word, Excel, PowerPoint) and experience with SharePoint
- Must have the ability to successfully coordinate activities with site functional departments
- Promotes a GxP and Quality mindset at all levels
Education and Experience:
- Bachelor’s degree in a physical science 2 + years of GMP experience.
- Associates degree with 5+ years of equivalent/relevant experience may be substituted in lieu of advanced educational requirement. Required for candidate to have GMP experience.
