Senior Quality Assurance Manager (REMOTE)RK3824 12 Months Dublin We're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties: Be an integral quality member of a cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain XPD, etc.Negotiator and Approver of quality agreements.Lead the preparation of the site for and represent at product-specific Regulatory Inspections and/or during Notified Body audits of CM Site, as applicable or required.Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas.Review / Approve Master Batch Records.Quality approver for deviations, change controls, CAPA.Prepare inspection playbooks.Identify and mitigate Risk at the CMO or testing Laboratories and/or escalate to management.Perform Person in Plant activities as required.APR Data Provider.Manage Audit commitments to completion.Perform tactical batch disposition activities in support of lot release.Decision to release or reject batches (Dynamic is different for SREs).Decision to approve or reject deviations, Change Control, CAPA.Decision to approve QAGR.Provide Quality position on GMP related topics and strategy for the site.Decision to approve Master batch Records/Raw Material Specifications.Education and Experience: Bachelor's degree.10+ years biotech or pharmaceutical industry experience.European Languages - desirable not essential.Significant Quality experience at Aseptic Manufacturing facilities.Able to facilitate and influence senior stakeholders and partners.If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
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