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Head of Quality Unit (m/f)

  • Ph.D. Chemist or Pharmacist or Medicinal Chemistry
  • Expert Knowledge in cGMP, QC & Analytic, Quality Assurance
  • Experience in a Quality Unit of a cGMP environment (drug substances or drug products)
  • Experience in international management (advantageous in Asian region)
  • Leading the Quality Unit with the subunits QA, Q-Systems and QC & Analytics
  • Main contact in all Regulatory Affairs questions related to Carbogen Amcis China
  • Develop, establish and continuously improve the quality system in cooperation with subject matter experts of the company
  • Assure cGMP compliance throughout the organization
  • Represent the Quality Unit of Carbogen Amcis China in the leadership team of Carbogen Amcis China and in the Corporate Quality Organization of Carbogen Amcis
  • Represent Carbogen Amcis China and its quality management system in authority- and customer matters (e.g. audits visits, contracts & administration)
  • QP responsibility
  • Build up and maintain effective and cGMP compliant processes and work flows and represent them in internal and external inspections. Take process ownership
  • Preparation of cGMP compliant documents (e.g. specifications, method descriptions, SOPs, validation protocols and -reports, transfer protocols and -reports, etc.)

» Job description

Shanghai [Volksrepublik China]

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