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 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.
Life Science Recruitment
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