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A distinguished pharmaceutical brand is seeking a QC Laboratory Specialist/Analyst in Singapore to ensure products meet quality and regulatory standards. The role involves performing chemistry tests and method validation in a GMP environment. Candidates should have a diploma in a relevant field and 3-5 years of quality control experience. A competitive salary and opportunities for professional development are offered.
About
We are a distinguished pharmaceutical brand with over sixty years of expertise, now expanding regionally in Singapore as our Southeast Asia hub. We are seeking a QC Laboratory Specialist/Analyst to ensure that products meet established quality, GMP and regulatory standards. This role will involve performing chemistry tests for raw materials, excipients, active ingredient, work in progress, and finished products. The role will also involve method validation to ensure compliance with GMP, regulatory standards, and internal quality policies.
Responsibilities
1. Sample Preparation and Testing
Prepare and test samples from all phases of the manufacturing process, including raw materials, in-process samples, and finished products, to ensure they meet required specifications and quality standards.
Conduct various chemical, or physical analyses using techniques such as HPLC, GC, Karl Fischer titration, and other laboratory equipment.
Perform stability testing and method validation as required.
2. Data Recording and Reporting
Accurately record, interpret, and report test results in accordance with Good Laboratory Practice (GLP) or Good Manufacturing Practice (GMP).
Review and analyse data to identify discrepancies or trends and participate in laboratory investigations when necessary.
3. Compliance and Documentation
Ensure all laboratory activities comply with internal SOPs, regulatory requirements and industry standards36.
Assist in writing and revising SOPs, assay sheets, and other control documents.
Maintain laboratory records, including data sheets.
4. Laboratory Operations and Maintenance
Perform routine maintenance, calibration, and troubleshooting of laboratory equipment.
Manage laboratory housekeeping, reagent and consumable inventory, and waste disposal.
Support audits and inspection readiness by ensuring documentation and laboratory practices are always compliant.
5. Continuous Improvement and Training
Participate in continuous improvement initiatives, such as updating test procedures or improving assay design.
Qualifications & Skills
Diploma in Chemistry, Pharmaceutical Sciences, or a related field.
Minimum of 3 to 5 years of experience in chemistry within a pharmaceutical or GMP-regulated manufacturing environment.
Hands-on experience with chemistry testing, equipment qualification, and environmental monitoring in a QC lab.
Strong understanding of QC equipment qualification and validation processes.
Knowledge of chemistry data analysis, interpretation, and reporting.
Experience in preparing for and supporting GMP inspections is highly desirable.
Excellent attention to detail, communication, and problem-solving skills.
What We Offer:
Competitive salary and benefits package.
Opportunities for professional development and advancement.
A dynamic and collaborative work environment.