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.