Regulatory Compliance Specialist

Vor 5 Tagen


YverdonlesBains, Waadt, Schweiz Incyte Vollzeit

Job Description

Key Areas of Responsibility
  • Quality Assurance Team Management: Lead the Quality Assurance team of Quality Control and Release, ensuring compliance with Incyte's quality policies, cGMP regulations, and international standards.
  • Qualification and Validation: Develop and implement quality systems, including qualification and validation activities, to ensure business growth.
  • Release Management: Drive the release of Raw Materials and Drug Substances according to Incyte Quality Policies and regulatory requirements.
  • Supply Chain Collaboration: Collaborate with Supply Chain and Regulatory functions to ensure seamless operations.
Requirements
  • Bachelor's Degree in relevant field such as Chemical Engineering, Bio-engineering, or Bioprocessing.
  • Expertise in microbiology and thorough knowledge of biotechnology processes, manufacturing, and laboratory equipment.
  • Demonstrated proficiency in good practice requirements cGMP and biopharmaceutical industry regulations and standards.
  • Strong analytical and problem-solving skills to drive business growth.


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