Senior QC Scientist - cGMP Quality & Compliance Lead

NUSANTARA PRIME CONSULTING PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

NUSANTARA PRIME CONSULTING PTE. LTD. is seeking a QC Specialist to manage test samples across in-process, release, and stability programs. The role focuses on ensuring traceability, documentation, and compliance in a fast-paced biopharma environment.

The position requires 3–5 years in biotech/pharma with a solid understanding of cGMP, regulatory guidelines, and quality control processes. Contract duration is 12 months and will involve on-site work in Singapore.

Qualifications

• Bachelor's degree or higher in a related scientific discipline.
• 3–5 years of experience in biotech/pharma industry.
• Strong understanding of drug development lifecycle and QC processes.
• Solid knowledge of cGMP and compliance mindset.
• Familiarity with FDA/EMA/ICH guidelines.
• Experience with regulatory submissions (IND/IMPD, NDA, ANDA).
• Excellent documentation and communication skills.
• Ability to work in fast-paced, regulated environment.

Responsibilities

• Manage QC test samples (in-process, release, environmental monitoring).
• Oversee stability sample management, storage, and testing schedules.
• Maintain regulatory retention and reference samples per requirements.
• Ensure accurate documentation and traceability of samples.
• Support laboratory operations: receipt, storage, distribution, disposal.
• Ensure QC activities meet cGMP, data integrity, and EHS standards.

Skills

Quality control

Documentation

Regulatory compliance

Regulatory submissions

Organizational skills

Education

Bachelor's degree in Pharmacy/ Chemistry/ Biochemistry/ Analytical Chemistry

Job description

NUSANTARA PRIME CONSULTING PTE. LTD. is seeking a QC Specialist to manage test samples across in-process, release, and stability programs. The role focuses on ensuring traceability, documentation, and compliance in a fast-paced biopharma environment.

The position requires 3–5 years in biotech/pharma with a solid understanding of cGMP, regulatory guidelines, and quality control processes. Contract duration is 12 months and will involve on-site work in Singapore.