QA Specialist/ Supervisor

BeiGene

Responsibilities:

  • Initiate QA SOPs and coordinate the initiation, review and approval of SOPs and documents.
  • Ensure the efficient distribution and withdrawal of records, SOPs and protocols.
  • Collect and archive the required documents.
  • Manufacture monitoring /Review the Batch Manufacturing / Packing Records.
  • Review/ approve label artwork.
  • Responsible for training management, develop training plan, prepare GMP training materials.
  • Ensure the cGMP compliance.
  • Manage validation plan and follow up execution, review validation protocols and reports.
  • Manage change control & deviation & CAPA.
  • Assist QA Manager to prepare regulatory and participate vendor audit.

Requirements:

  • Bachelor degree or above in Pharmaceutics/Chemistry or related degree
  • Experience 3-5 years in quality assurance management, quality control background and expertise is a plus
  • Familiar with regulations, (C)FDA cGMP/GLP, ICH guidelines and Pharmacopoeia
  • Good Leadership and communication skills
  • Fluent in English

To apply for this job email your details to hr@beigene.com

Apply using webmail: Gmail / AOL / Yahoo / Outlook