Quality Assurance Specialist

Job Title:

Experience Required:

Location:

Responsibilities

• Perform end-to-end quality control testing of pharmaceutical/biological products, covering both microbiological and chemical analysis.
• Conduct microbiological assays including sterility testing, microbial limits, endotoxin testing, and environmental monitoring.
• Execute chemical testing of raw materials, intermediates, and finished products using techniques such as HPLC, GC, UV, and wet chemistry.
• Maintain and calibrate laboratory instruments, ensuring accuracy and reliability of test results.
• Review, document, and interpret QC data in compliance with GDP and regulatory standards (USFDA, EMA, WHO, etc.).
• Support method validation, stability testing, and release activities for raw materials and finished goods.
• Adhere to GLP, GMP, and safety practices while performing laboratory operations.
• Investigate OOS/OOT results, deviations, and support CAPA implementation.
• Train and mentor junior QC analysts in both microbiology and chemistry techniques.

Key Skills

• Microbiological testing (sterility, endotoxin, microbial limits, EM)
• Analytical techniques (HPLC, GC, UV, FTIR, titrations, wet chemistry)
• Knowledge of GMP, GLP, GDP, and regulatory compliance
• Data integrity and technical documentation
• Instrument calibration and troubleshooting
• Root cause analysis and problem-solving
• Training and mentoring ability