全职 Senior QC Scientist 工作, 薪水, NUSANTARA PRIME CONSULTING PTE LTD (Nusaprime) 公司招聘中

Senior QC Scientist

Singapore

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工作地点

职位描述

岗位职责

Main Responsibilities

Manage QC test samples, including in-process, release, environmental monitoring, drug substance, and excipient samples.
Oversee stability sample management to ensure proper storage, tracking, and testing schedules.
Maintain regulatory retention samples and reference samples in compliance with applicable requirements.
Ensure accurate documentation and traceability of all sample management activities.
Support laboratory operations by coordinating sample receipt, storage, distribution, and disposal.
Ensure all QC activities are conducted in compliance with cGMP, data integrity, and EHS requirements.

About You

Bachelor's Degree or higher in Pharmacy, Chemistry, Biochemistry, Analytical Chemistry, or a related scientific discipline.
3–5 years of experience in the biotechnology, biopharmaceutical, or pharmaceutical industry.
Strong understanding of the drug development lifecycle and quality control processes.
Solid knowledge of cGMP requirements and a strong quality and compliance mindset.
Familiarity with global regulatory requirements and guidelines, including FDA, EMA, NMPA, ICH, WHO, USP, Eur. Ph., and ChP.
Good understanding of regulatory submissions, including IND/IMPD, NDA, and ANDA filings.
Strong organizational, documentation, and communication skills.
Ability to work effectively in a fast-paced and regulated environment.

Contract Duration: 12 months

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