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Dublin - Sr Associate QA

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Dublin - Biotechnology - Amgen

Job DescriptionPosition Title: QA Snr AssociateReports to: QPGroup/Division: Amgen Dun LaoghaireDepartment: QAShift Yes 24/5Position Summary:This job specification outlines the general responsibilities associated with the role of QA Snr Associate at ADL. The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard. This means that they may be asked to carry out additional work functions that are not described in this specification but are associated with their role. The QA Snr Associates duties are as follows;• Compiles QC and Manufacturing batch records and reviews for compliance to cGMPs and Product Licenses.• Review and approve Master Batch Records• Review non conformances for completeness• Prepare the agenda for Site Quality Review Team and submits non conformances for review/discussion.• Prepares the SQRT minutes.• Assigns expiry date to products.• Prepare deviation trend reports bi annually to establish any evident trends.• Schedules products to be placed on the stability program• Status changes and yields product on the computer system• Prepares non conformance reports for shipments as required• Tracks CAPA’s detailed in non conformance reports• Writes, reviews and ...


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Available Jobs Biotechnology

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