In conjunction with quality engineering, ensure any deviations/NCEs associated with batches are in compliance prior to release.
Prepare and review all extractable samples as required.Batch Manufacturing Records Review:Verify accuracy of all records within the BMR.Verify that all activities within the BMR in respect to metrology, inspection, production, line clearance records etc.
have been completed effectively.Ensure effective resolution on any inaccuracies identified within the BMR.Ensure records are maintained to support easy retrieval and preservation.Release of components and final products in SAP system based on approved batch files.Report all paperwork issues to the relevant Team Leader/Manager in a timely manner.Complete Incoming Inspection activities, including taking of samples for Incoming Inspection requirements, and relevant paperwork.Liaise with Warehouse/Supply Chain regarding batch release activities.Record available stock counts for prioritizing batch release activities.Request data from Moulding QC Lab and calculate Cpk values for all relevant product, work with QC Lab and Team Leader to resolve issues on any calculated Cpk failures requiring re-measures.Devise/Update Work Instructions as required.Support all company safety and quality programs and initiatives.Ensure ongoing compliance with GMP in all practices, recording of events and processes.Ensure compliance with all learnings from all GMP training events.Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.Job Specifications: The minimum education and experience required to perform this job competently.
Leaving Certificate or equivalent.Basic quality control concept understanding (desirable: experience within a quality control role).Administration and record control experience.Understanding of Metrology desirable.Skills/Attributes:Excellent initiative, decision-making and be able to work in a core team environment.Energetic and enthusiastic individual wanting to make a difference.Performance and results driven.Excellent attention to detail with strong GMP and GDP understanding.Proficient in Microsoft Office.Organization Linkages: List the titles of individuals and organizations with which this position has the most frequent and significant contact.
Briefly describe the nature of those contacts.
Reports to Quality Lead / Site Quality Manager.Operations and Departmental Managers.Quality Team.Supply Chain and Warehouse Teams.
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