Regulatory Compliance Specialist
Vor 5 Tagen
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.
- 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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