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Quality Assurance Consultant

Job ID: 220489

Location: Dundalk, Louth , IE, A91 X56F

Summary:

Perform tactical work and review a variety of documents, protocols, and reports.

Project Details:

  • Exhibit varying levels of experience and a solid progression of work and/or training
  • Document, review and batch disposition of API and drug product used in Phase 1-3 clinical studies
  • Review and approve manufacturing records, change controls, investigations and analytical data
  • Review and approve test methods and method validations
  • Review manufacturing validation protocol and reports

Job Experience:

  • Experience in small molecule manufacturing and contract manufacturing
  • Bachelor's degree in Engineering, Chemistry, Biology, or other related discipline
  • A minimum of 5+ years' work experience in the Quality organization of a Medical Device and/or Pharmaceutical company
  • Knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring, Manufacturing operation, etc.
  • Excellent verbal and written communication skills
  • Demonstrate ability to effectively collaborate and partner with all levels of management while maintaining an appropriate assertive style is critical
  • Strong analytical skills
  • Effective project management and organizational skills are essential
  • Knowledge and understanding of quality
  • Manufacturing processes and procedures, planning, supply chain, inventory management

Language Required: English

Oxford is an Equal Opportunity Employer. All applicants will receive consideration for employment without regard to race, ethnic origin, religion, sex, age, sexual orientation, gender identity, national origin, disability, or any other characteristic protected by law. All persons hired will be required to verify identity and eligibility to work in the Country in which they have applied to work.

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