Quality Audit Manager
800K~1M CNY/Per year
Full-time
More than 10 years
Refresh at a year ago
615 Views
21 Apply
Shenzhen
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Job responsibilities
Job Description:
1, Plan and execute comprehensive GMP compliance audits for dietary supplement ingredient manufacturing suppliers, including but not limited to: quality system audits, production process audits, and facility/equipment audits. Conduct regular surveillance audits of key suppliers to drive continuous improvement of the quality systems.
2, Research and interpret product access regulations for global target markets, providing proactive compliance support for new product introduction and market expansion.
3, Evaluate and lead efforts to obtain necessary international product certifications based on market demands. Oversee the end-to-end management of certification projects such as NSF, USP, and SGS conformity assessments, and ensure the establishment and ongoing compliance of CGMP systems (requiring proficiency in 21 CFR Part 111 & 21 CFR Part 117). Responsible for the maintenance, renewal of all certifications, and managing audits conducted by customers and certification bodies.
4, Responsible for connecting with cooperative factories (pharmaceutical production enterprises) and providing good export technical guidance.
5, Establish quality control procedures for dietary supplement ingredient exports, ensuring consistent quality for each batch of goods. Handle customer quality complaints and feedback.
Job Requirements
Qualifications:
1, Bachelor's degree or higher in Pharmacy, Chemistry, or a related field.
2, Fluent in English (spoken and written); proficiency in Chinese is a strong plus.
3, High moral character, strong sense of responsibility, and a team-oriented spirit.
4, Strong service mindset and good organizational skills.
5, Minimum of 10 years of QA, RA, or GMP-related work experience in the dietary supplement industry. Familiarity with pharmaceutical GMP quality management systems and ICH guidelines. Experience participating in audits conducted by international clients is required.
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