Quality Vendor Manager #JN -122020-57995

Smyrna, Georgia
Industry: Business Analyst / Project Manager
Job Number: JN -122020-57995

Description:

  • In this transversal matrix role you will provide Quality expertise and support to a group of Vendor Quality Lead professionals who manage and oversee operational quality management of externalized manufacturing activities for intermediates, APIs, bulk and finished drug products
  • Your key responsibility will be to review and assess e.g
  • Product Quality Reviews
  • Stability Protocols and Reports
  • Quality Agreements (draft and updates)
  • Deviations in manufacturing and quality control
  • Out-Of-Specification and Out-Of-Trend results (identified during release or stability testing)
  • Change Controls
  • Investigations & root cause analyses related to deviations, complaints etc

Major Accountabilities:

Support to Vendor Quality Leads

  • Review annual stability protocol and reports. Communicate any trends to the Vendor Quality Lead (VQL)
  • Perform review of CMO PQR within agreed timeframe, complete PQR Assessment and discuss outcome with VQL
  • Participate to Quality Agreements (QAA) periodic reviews and draft QAA according to available templates
  • Perform stakeholder review of various change controls, support change control preparation, keeping change control trackers up to date accordingly. Participate on ad-hoc basis to the UCB Product Change Control Committees
  • In specific cases, review Validation and Technical Transfer protocols and reports liaising with VQL.
  • Review Master Batch records changes linked to change controls or to support initiation
  • investigations/deviations/ out-of-specifications. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders

Education:

  • Bachelor's Degree

Experience:

  • 5-10 years professional experience & knowledge in a Quality role in the pharmaceutical industry preferably in the GMP operations environment
  • Knowledge with pharmaceutical formulations (e.g., tablets, capsules, oral solutions, injectables, transdermal systems)
  • In-depth knowledge with the manufacture / testing of pharmaceutical formulations (e.g., tablets, capsules, oral solutions, injectables, transdermal systems)
  • Hands-on field experience in failure investigations, root cause analysis, deviation review
  • Solid knowledge about European Good Manufacturing Practices

Position Title:                Quality Vendor Manager

Location:                        Smyrna, GA

Duration:                       11 months



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