Qc Chemist

apex laboratories; Chennai; On-site; INR 400,000 - 700,000; Full time

Job summary

Apex Laboratories in Chennai, Tamil Nadu, India seeks a QA/QC analyst to perform raw material testing, in-process checks, finished product analysis and stability studies. The role involves operating HPLC, GC, UV-Vis spectrophotometers and Karl Fischer instruments with strict adherence to GMP/GLP and ALCOA+ data integrity rules.

You will document results, report deviations promptly, and ensure batch release quality by maintaining thorough lab records and compliance with regulatory standards.

Qualifications

• GMP awareness is required.
• Knowledge of GLP and QA practices is essential.
• Commitment to ALCOA+ data integrity principles.

Responsibilities

• Raw Material Testing: Analyze incoming APIs, excipients, and packaging materials for identity, purity, and strength.
• In-Process Checks: Perform testing during manufacturing to verify validated parameters.
• Finished Product Analysis: Test for assay, dissolution, impurities, and microbial limits before release.
• Stability Studies: Monitor product stability under varied temperature and humidity.
• Equipment & Calibration: Operate, calibrate, and troubleshoot lab instruments (HPLC, GC, UV-Vis, Karl Fischer).
• Documentation & Compliance: Record data per GMP/GLP and ALCOA+; report OOS or deviations.

Skills

GMP awareness

GLP knowledge

Data integrity

Documentation

Tools

HPLC

GC

UV-Vis

Karl Fischer

Job description

Role & responsibilities

• Raw Material Testing: Analyze incoming active pharmaceutical ingredients (APIs), excipients, and packaging materials for identity, purity, and strength. [1, 2]


• In-Process Checks: Perform regular testing during manufacturing to confirm each production step meets validated parameters. [1, 2]


• Finished Product Analysis: Conduct final laboratory testing for assay, dissolution, impurities, and microbial limits before batch release. [1, 2]


• Stability Studies: Monitor how drug products behave over time under various temperature and humidity conditions to establish shelf life. [1, 2]


• Equipment & Calibration: Operate, calibrate, and troubleshoot analytical lab instruments like HPLC, GC, UV-Vis spectrophotometers, and Karl Fisher apparatus. [1, 2]


• Documentation & Compliance: Record data accurately in line with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and ALCOA+ data integrity rules, while reporting out-of-specification (OOS) or deviation events