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Quality release inspector

Waterford
RPG Recruitment
Inspector
Posted: 14 June
Offer description

Quality Release Inspectorrole in leading FDA environment. This Key role supports the Quality Function.Key Responsibilities and End Results: (Essential responsibilities include but are not limited to the following): 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 timely manner. 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. 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 prioritising 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. Role will suit Qualification in administration A min of 2 years experience supporting a Quality Department in a large manufacturing environment, ideally FDA environment Strong communication skills Fluency in oral and written English essential Strong computer skills Strong Team player skills Skills: Quality QC Batch Manufacturing Records

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