QA Engineer (API)

1. On-site Compliance
Perform daily on-site monitoring of API workshops (synthesis, purification, drying, packaging); oversee implementation of Critical Process Parameters (CPP).
Supervise intermediate material transfer to ensure controlled movement of materials.
Conduct dynamic environmental monitoring in clean areas (Grade D/C).
2. Deviation & Change Management
Lead or participate in deviation investigations, focusing on yield anomalies, out-of-specification impurities, and residual solvent exceedances.
Review change controls, especially major changes related to synthetic routes, starting material suppliers, and solvent recovery processes.
3. Validation
Review cleaning validation protocols and reports; evaluate residue limits and hardest-to-clean locations.
Review process validation protocols and reports; focus on stability data, yield fluctuations, and impurity profile analysis.
4. Material & Solvent Management
Responsible for supplier audits and release review of starting materials, critical materials, solvents, and catalysts.
Supervise quality management of solvent recovery systems to prevent cross-contamination.
5. Quality Review & Impurity Management
Assist in Annual Product Review (APR); analyze trends in impurities, yield, and complaints.
Participate in genotoxic impurity risk assessments and control strategy development.
Qualifications
Education
Bachelor’s degree or above in Organic Chemistry, Medicinal Chemistry, Pharmaceutical Engineering, or related fields.
Experience
3+ years of QA experience in API manufacturing.
Familiar with synthetic API manufacturing processes; experience supervising reactors, centrifuges, dryers, etc.
Experience in sterile API is preferred.
Technical Skills
Proficient in ICH Q7, China GMP, and API appendices.
Familiar with impurity study principles (ICH Q3A/Q3B/Q3C) and basic concepts of genotoxic impurity assessment (ICH M7).
Proficient in risk management tools such as FMEA.
Good English reading and writing skills.
Core Competencies
Strong sense of principle and logical reasoning in chemistry.
Able to work in chemical production environments; strong cross-departmental communication skills.