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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Senior Plant Technical Quality Assurance Specialist


Reference:RK3131 Location: Dublin
Qualification:DegreeExperience:7-9 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist

Senior Plant Technical Quality Assurance Specialist
RK3131
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:

  • Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products, ensuring that all activities meet regulatory expectations.
  • Quality review and approval of Process Development and Validation documentation
    • Technical transfer documents
    • Validation Protocols, executed validation documents and reports
  • Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
  • Perform all activities in compliance with safety standards and SOPs
  • In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role



Education and Experience :
  • Science or Engineering Degree related discipline preferred.
  • 7yrs + working in the pharmaceutical or biotechnology industry as a Subject Matter Expert
  • Experience in change control, Deviation, corrective and preventative actions (CAPA’s) and validation practices.
  • Experience in aseptic manufacturing is preferred




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