Quality Specialist - NPI

  • Dublin
  • Temporary 12 months
  • JO-1903-64297_1551707794

Summary

Responsibilities

  • Provide quality and cGMP input and oversight focused on the transfer of new products to the site - through commercial readiness and ongoing product disposition for biologics facility.
  • Provide QA support for risk-based verification activities in the capacity of Quality Assurance Subject Matter Expert.
  • Support the introduction of all associated new materials, including qualification of the materials and associated vendors.
  • Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained / controlled.
  • Review and approval of technical support documentation. (Examples include associated technical transfer documentation, process, method validation)
  • Review and approval of manufacturing batch records.
  • Review and approval of functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols).
  • Provide quality support for implementation of new product on SAP.
  • Authoring, review and approval of QA-related procedures.
  • Oversee the effective documentation and tracking of quality management system activities including deviations and change controls, CAPA, and batch disposition.
  • Review and approve Validation protocols and reports as required.
  • Support the vendor quality management programme.
  • Participate in regulatory inspections as required.
  • Represents Quality Assurance to guide various projects and technical meetings, as needed.
  • Responsible for documenting and reporting compliance issues to management.
  • Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.


Requirements

  • B.Sc. in science/pharmacy/engineeringwith a minimum of 3 years' experience in cGMP Quality environment
  • Min 3 years QA experience in a pharmaceutical manufacture/biopharmaceutical environment.
  • Should have strong process knowledge to include upstream and/or downstream processing.
  • An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.

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