QA Entry Engineer-Contract

Collins Mcnicholas Recruitment

Tipperary

Role Responsibilities: 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. Role Requirements: 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 aisling.lane@collinsmcnicholas.ie. For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our consultants to discuss all the latest jobs! This job originally appeared on RecruitIreland.com.

1860 days ago