Regulatory Compliance Specialist

1 week ago


Étreux, Hauts-de-France, United States Verista Full time

Responsibilities

The Senior Quality Specialist will be responsible for:

  • Providing quality oversight and support to site Cell and Gene Therapy operations
  • Leading QA efforts to establish new programs supporting Drug Product facility start-up
  • Reviewing batch data, including batch records, deviations, in-process data, EM data, and QC release testing
  • Approving COAs and product releases
  • Providing production floor support and guidance for GMP product quality and compliance
  • Resolving product quality investigations and quality issues
  • Developing and delivering technical training programs
  • Supporting drafting and revising Quality Agreements between CMOs/Suppliers and site


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