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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Senior Quality Assurance Manager - Remote


Reference:RK4280 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Manager

Senior Quality Assurance Manager (CMO)
Remote
RK4280
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


Education and Experience :
  • Bachelor’s degree in a Science related field is required.
  • 10 + years biotech or pharmaceutical industry experience
  • Significant Quality experience at Aseptic Manufacturing facilities
  • Have a good oversight of deviation management, reg affairs, filings, regulatory, the guidance, e.g., HPRA requirements, so a very broad experience in quality.
  • Previously worked in an external manufacturing environment.


If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or [email protected] for further information.