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Senior QC Scientist
NUSANTARA PRIME CONSULTING PTE. LTD. · Singapore
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Job description
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
Nusantara Prime Consulting Pte. Ltd (NPC) is a Singapore based private limited company that focuses on technical consulting solutions led by a team of industry practitioners.
Our Specialist Services include Pharmaceutical focus on Process/Project Engineering and Design, Project Management, Technology Transfer, Regulatory affairs, Commissioning, Qualification, Validation, Quality Assurance & Control and Waste Water processing consultation with aim of ZLD (Zero Liquid Discharge) for a circular economy to clients in the Biopharmaceuticals, Life Sciences and Food and Beverage (F&B) industry in the ASEAN region.
Our Mission
With a holistic thought process, we are dedicated to partnering with our clients on end-to-end solution support delivering life-saving therapeutic drugs to the patients.
Our Vision
To be the most successful and ground-breaking consulting agency; providing best-in-class products and services to support our customers in producing quality healthcare timely and economically.
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