QA??? ??-?????? - Hengrui Pharma : Job Details

QA??? ??-??????

Hengrui Pharma

Job Location : Princeton,NJ, USA

Posted on : 2025-10-10T18:20:37Z

Job Description :

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5.??QC????????????????????????????

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???????FDA/EMA/WHO/ICH/NMPA????

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Main Responsibilities

Participate in maintaining and optimizing the quality management system covering the entire drug lifecycle.

Participate in audit projects conducted by global health authorities such as FDA and EMA.

Engage in quality incident management, including deviation investigations, change control, and CAPA effectiveness evaluation.

Manage overall quality compliance for product release testing and stability studies.

Monitor QC laboratory data integrity systems to ensure analytical activities comply with global pharmacopeia requirements.

Review compliance of analytical method transfer and validation.

Collaborate with production, R&D, procurement, and other departments to ensure effective implementation of quality standards.

Qualifications

Education:

Masters degree or above in Pharmacy or related fields; PhD preferred.

Experience:

Familiar with regulatory frameworks of FDA/EMA/WHO/ICH/NMPA.

Language:

Fluent in English (listening, speaking, reading, writing).

Other Skills:

Proficient in using office software.

Additional Competencies:

Strong interest in pharmaceutical production with willingness for long-term development in this field.

Clear logical thinking and a rigorous scientific mindset.

High initiative, strong learning ability, and enthusiasm.

Apply Now!

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