QA Specialist
7 days ago
Transform the Treatment Paradigm
As a QA Specialist for Medical Products marketed to the Chinese Market, you will play a pivotal role in ensuring the quality of our products meets the highest regulatory standards. Your expertise will drive innovation, transforming the treatment paradigm for chronic diseases relying on injection-based therapies.
The Position
- Develop and implement quality management systems to ensure compliance with regulatory requirements, including cGMP, ISO 13485, and EU GMP Annex 16.
- Lead audits and inspections, leveraging your extensive experience in GMP regulated pharmaceutical industry.
- Collaborate with cross-functional teams to maintain a robust quality management system, ensuring seamless execution of production and quality processes.
- Participate in signal processing, risk management, and CAPA/QMT handling to drive quality improvements.
- Develop and maintain expertise in regulatory requirements, industry guidelines, and Novo Nordisk policies.
- Contribute to the development of quality-related processes, ensuring alignment with external requirements and Novo Nordisk's interpretation.
- Provide guidance and advice on cGMP interpretation, leveraging your expertise to support the organization.
- Ensure compliance with marketing authorization, rules, regulations, and requirements regarding quality at site STJ.
- Act as a key member of local audits and inspections, supporting the quality management team.
Qualifications
- Bachelor's degree or Master's degree in Pharmacy, Biology, Chemistry, or a related field.
- Excellent command of written and spoken English.
- Minimum 10 years' experience from production or Quality area in GMP regulated pharmaceutical industry.
- Full of experience in audit and inspection.
- Deep understanding and expertise in regulatory requirements and industry guidelines for validation.
- Broad experience with quality systems and standards applied by Novo Nordisk.
- Living NN Way and Novo Nordisk policies.
- LEAN mindset integrated with quality mindset.
Geographic Responsibility: The position is geographically placed in Tianjin, with QA responsibility in STJ. Interaction with health authorities from countries worldwide is expected due to the position's key role in inspections.
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