Senior QC Scientist

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.