QC Specialist I - Raw Materials

SG12 (FCRS = SG012) Novartis Singapore Pharmaceutical Manufacturing Pte Ltd; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company in Singapore seeks a Quality Control professional to maintain compliance in the QC Raw Materials laboratory. The role involves leading method validation, release testing, and managing laboratory investigations, ensuring high standards of quality in a GMP environment.

Qualifications

• 5-10 years of relevant experience in Pharma/Manufacturing sector.
• Experience in Raw Material Lab and Method validation.

Responsibilities

• Maintain QC Raw Materials laboratory in full cGMP compliance.
• Lead raw material method validation and routine release testing.
• Prepare for health authority inspections and internal audits.

Skills

GMP

Quality Control

Analytical Skills

Education

University degree in Pharmacy

University degree in Chemistry

Job description

Key Responsibilities

1. Maintain QC Raw Materials laboratory in full cGMP compliance.
2. Lead raw material method validation/verification and routine release testing.
3. Plan day-to-day operational activities in QCRM (e.g., housekeeping, release testing). Perform data entry, review, and approval of RM packages for batch release.
4. Lead improvement projects and perform technical reviews of procedures and testing monographs for raw materials.
5. Lead laboratory investigations (e.g., OOS, deviation) and manage change controls for QC Raw Materials.
6. Create and revise RM testing monographs.
7. Prepare for and participate in health authority inspections and internal audits.
8. Perform other duties or projects as assigned by the QC Team Leader – Raw Materials.

Role Requirements

Essential Requirements:

• University degree in Pharmacy, Chemistry, or equivalent.
• 5-10 years of relevant experience in the Pharma/Manufacturing sector in an analytical lab within a GMP environment.
• Experience in Raw Material Lab and Method validation.
• Knowledge of GMP, Management of Quality Audit, Quality Change, Control, and Good Documentation.