- Determines suitably release by reviewing test results against product specification and by assessing the cumulative effect of lot deviations, notes and non-conformances. Releases product by performing the necessary transactions in System Applications and Products (SAP) to release the product upon receipt of the product release authorization and completion of technical review.
- Works with quality control/quality engineer departments to disposition identified quarantined lots on SAP.
- Reviews and approves Design History Files (DHF) by obtaining and verifying the contents of DHF’s and approving the change order authorizing release into the Archive department.
- Advises manufacturing personnel and project leaders by functioning as the “expert” in the area of documentation compliance.
- Co-ordinates clinical product by completing appropriate paperwork to release clinical product to approved sites.
- Audits materials or the work of others through the examination, inspection, measurement, or test of raw materials, components, sub-assemblies and documentation.
- Gains understanding of manufacturing process by becoming familiar with systems applications and critical process steps.
- May assist in validation activity through the review of manufacturing documentations and protocols.
- Notifies personnel of product release issues by providing feedback immediately upon discovery of issues, and, on a periodic basis, informing relevant personnel in a more formal manner of discrepancies found at lot review.
- National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline. Relevant work experience advantageous but not essential or an equivalent combination of education and work experience.
- Basic technical knowledge of concepts, practices and procedures. Limited understanding of business unit/group function. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in non-compliance with governmental regulations.
- Learns to use professional concepts and company policies and procedures to solve routine problems. Works on problems of limited scope. Minimal independent decision making.
- Begins developing a network of internal resources to facilitate completion of tasks. Individual influence is typically exerted at the peer level.
- Completes daily work to meet established schedule with guidance from supervisor on prioritization of tasks.
- May exercise authority within pre-established limits and approval. Failure to achieve results can normally be overcome without serious effect on schedules and programmes.
- Works under general supervision. Follows established procedures. Work is reviewed for soundness of technical judgment, overall adequacy, and accuracy.
- May provide limited work direction and guidance to skilled non-exempt levels of employees.
For a confidential discussion and more information on the role, please contact Aisling Lane on 021-4320675 or email firstname.lastname@example.org