Quality Assurance Specialist
4 weeks ago
Are you passionate about driving innovation in the pharmaceutical industry? Do you want to make a meaningful impact on the lives of patients? We're seeking a highly skilled Quality Assurance Specialist to join our team at Novo Nordisk A/S.
Key Responsibilities:
1. Quality and Compliance Expertise
Provide quality and compliance-related input and make decisions on quality and compliance-related issues. Develop and implement quality-related processes and procedures to ensure compliance with regulatory requirements.
2. QA Presence and Issue Handling
Perform QA presence for responsible areas and handle relevant issues. Conduct audits and inspections to ensure compliance with quality and regulatory requirements.
3. SOP Development and Training
Establish SOPs for quality-related processes and procedures. Provide training to employees within and outside of the quality assurance department on quality-related topics.
4. Regulatory Affairs and Audits
Handle and answer internal and external audits and regulatory affairs inquiries. Ensure compliance with regulatory requirements and industry standards.
Qualifications:
4-year (BS) degree in Pharmaceuticals, Engineering, or related field. Fluent in written and spoken English. Minimum 3 years of experience in quality assurance and/or working in a similar position. Good knowledge of regulatory requirements and expectations from SFDA and EU.
What We Offer:
A dynamic and collaborative work environment. Opportunities for professional growth and development. A competitive salary and benefits package.
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