Quality Assurance Expert

4 weeks ago

Tianjin, Tianjin, China Novo Nordisk AS Full time

Are you passionate about enhancing healthcare solutions for patients? Join us at Novo Nordisk, where we strive to revolutionize treatment methods for chronic diseases that traditionally depend on injection therapies.

Position Overview:

  • Role: As a Quality Assurance Expert for medical products aimed at the Chinese market, you will:
  • Ensure Compliance: Guarantee that products are manufactured, tested, and released in alignment with applicable regulations, registration documents, and quality standards.
  • Manage Deviations: Engage in the resolution of escalated deviations following established procedures.
  • Customer Complaints: Review and assess customer complaints prior to case closure.
  • Quality Oversight: Act as a Qualified Person substitute in the absence of the QP.
  • Annual Product Review: Evaluate the Annual Product Review, including adverse event reports and ongoing stability study results.
  • Site Master File Review: Conduct assessments of the Site Master File.
  • Production Decisions: Participate in decisions regarding the initiation of production in new facilities or modifications to existing production lines.
  • Service Level Agreements: Review service level agreements between contract manufacturers and Novo Nordisk A/S.
  • Critical Deviations: Approve critical deviations when necessary.
  • Product Specifications: Approve specifications for products and materials.
  • Quality Management System: Contribute to maintaining the Quality Management System.
  • Internal Audits: Participate in internal audits and inspections.
  • Regulatory Analysis: Engage in the analysis of new regulations.
  • Quality Management Review: Take part in quality management review meetings.
  • CAPA Handling: Involve in corrective and preventive actions and quality trend management.
  • Risk Management: Participate in quality risk management processes.
  • Validation Activities: Engage in validation activities, ensuring quality oversight.
  • Product Recall: Participate in potential and actual product recalls.
  • Compliance Assurance: Ensure adherence to marketing authorizations and quality regulations.
  • Expert Counsel: Act as a consultant for quality issues across various sites.
  • Process Management: Establish and manage compliant processes across functions.
  • Knowledge Sharing: Share expertise on complex processes within the organization.
  • Guidance on cGMP: Provide insights on current Good Manufacturing Practices.
  • Technical Responsibilities: Uphold technical responsibilities as a Quality Assurance Expert.
  • License Maintenance: Maintain the License to Operate, ensuring compliance with cGMP and ISO standards.
  • Quality Support: Provide quality support to production departments, ensuring KPIs are met.
  • Standardization Efforts: Support standardization and optimization initiatives.
  • Audit Participation: Act as a key member in local audits and inspections.
  • Team Collaboration: Participate in management meetings as part of the quality team.
  • Global Interaction: Communicate with health authorities worldwide.
  • Cultural Communication: Engage with international stakeholders, requiring strong communication skills.

Qualifications:

  • Bachelor's or Master's degree in Pharmacy, Biology, Chemistry, or a related field.
  • Proficient in written and spoken English.
  • At least 10 years of experience in production or quality within the GMP-regulated pharmaceutical industry.
  • Extensive experience in audits and inspections.
  • Deep understanding of regulatory requirements and industry guidelines for validation.
  • Broad experience with quality systems and standards.
  • Commitment to Novo Nordisk policies and principles.
  • Integration of a cLEAN mindset with quality awareness.

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