Quality Assurance Specialist

21 hours ago

bangalore, India Tek Support Full time

Job Title: Quality Control Specialist Trainer (Microbiology + Chemistry)

Experience Required: 8+ Years in Quality Control (Pharma / Biopharma / Medical Devices)

Location: Remote


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

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