Senior Quality Assurance Specialist
2 months ago
Key Responsibilities
- Quality Assurance
- Ensure compliance with cGMP, ISO13485, and EU GMP Annex 16
- Participate in audits and inspections
- Conduct quality risk management and validation activities
- Technical Responsibilities
- Maintain License to Operate
- Ensure compliance with regulations and industry guidelines
- Participate in standardization and optimization activities
- Geographic Responsibility
- Position is geographically placed in Tianjin, China
- QA responsibility in STJ
- Interaction with health authorities from countries worldwide
Qualifications
- Bachelor's degree or Master's degree in Pharmacy, Biology, Chemistry, or 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
- Have 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
- CLEAN mindset integrated with quality mindset
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