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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Senior Manufacturing Specialist


Reference:RK8225 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Manufacturing Coordinator

Senior Manufacturing Specialist
Remote
RK8225
Contract 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.


The Sr Associate Contract Development & Manufacturing provides technical support to the External Supply manufacturing team, solves complex production problems, and implements improvements to enhance efficiency and quality



Key Responsibilities:

  • The successful candidate is expected to own and execute various quality record types, including Deviations (Major/Minor), CAPA, SICAR, Change Control and perform metrics oversight responsibilities.
  • Liaise with Third Party CDMOs to maintain and monitor systems to ensure all record received are appropriately investigated and concluded per quality standards and procedures.
  • Support/Lead investigation teams to identify meaningful root causes and robust corrective and preventative actions by effectively utilizing advanced root cause analysis tools.
  • Optimise deviation management, corrective and preventive actions effectiveness to prevent reoccurring events.
  • Report Third Party CDMO site performance metrics to site lead; identify improvement opportunities for site performance.
  • Coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardisation of performance tools used by the Work Centre Teams (WCT)
  • Oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team
  • Facilitation of cross-functional teams (internal and external to External Supply).
  • Work closely with the suppliers and External Supply peers to address and close critical investigations and Corrective Actions. Participate in the assessment or implementation of continuous improvement projects or initiatives.
  • Communicate with all levels of the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metric generation and reporting.


Education and Experience:
  • Bachelor’s Degree (L8) in Business Administration, Engineering or Science-related field
  • 5 years of experience in GMP protein, API, DS, DP or packaging manufacturing environment
  • Experience in roles requiring knowledge of cGMP principles, FDA and other regulatory agency guidelines, and validation principles
  • Understanding of applicable manufacturing/testing processes (i.e. protein, API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
  • Experience with supporting/managing Third Party CDMO sites
  • Demonstrated experience with QMS & Digital tools including Veeva Vault, TrackWise, AI software.



If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.