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- 給料
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- 1
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- 7日前
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仕事内容
Job Overview
This position involves performing timely validation of analytical methods for drug products and APIs, including intermediates and key starting materials, which are intended for global filings. The role demands a solid understanding of current Good Manufacturing Practices (cGMP) and strong technical expertise to ensure the validated methods are suitable for their intended applications.
Key Responsibilities
- Perform timely validation of analytical methods for drug products and substances according to global filing requirements, with a focus on cGMP compliance and technical accuracy.
- Accurately document data generated during validation experiments as per established protocols and procedures.
- Collaborate and engage with the Internal Compliance team and R&D Quality-CQA to address queries arising during validation document reviews.
- Execute transfer of analytical methods across various plant locations prior to exhibit batches production.
- Maintain and ensure cleanliness and proper labeling in GMP areas, including systematic chemical storage.
- Continually update knowledge on regulatory guidelines and GMP standards related to method validation by participating in relevant trainings and SOP compliance activities.
- Carry out additional duties as assigned, either verbally or in writing.