Quality Control Executive

1 day ago

Salem, Tamil Nadu, India Cologenesis Healthcare Pvt Ltd Full time ₹ 1,80,000 - ₹ 2,76,000 per year

Analytical Method Validation Chemist:

Educational Background:

A Bachelor's or Master's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline is usually required.

Experience with Analytical Techniques: Hands-on experience with a variety of analytical techniques is crucial. Common techniques include:

  • High-Performance Liquid Chromatography (HPLC)
  • Spectrophotometry (UV-Vis,)
  • Electrophoresis (e.g., GelElectrophoresis)
  • Titration
  • Other specialized techniques like Kjeldahl, Karlf Fischer Titration, Potentiometer.

Executing Method Validation Experiments:

  • Perform the experiments outlined in the validation protocols with accuracy and precision.
  • Ensure proper handling of samples, standards, and reagents.
  • Operate and maintain analytical instruments (e.g., HPLC, spectrophotometers) according to established procedures.
  • Document all experimental work meticulously in laboratory notebooks and data sheets, following Good Laboratory Practices (GLP).
  • Troubleshoot any analytical issues that arise during the validation process.

Data Analysis and Report Generation:

  • Analyse the data generated from the validation experiments using appropriate statistical methods.
  • Evaluate the results against the pre-defined acceptance criteria.
  • Identify and investigate any out-of-specification (OOS) or out-of-trend (OOT) results.
  • Prepare detailed method validation reports summarizing the experimental procedures, results, statistical analysis, and conclusions.
  • Ensure that the validation reports are accurate, complete, and compliant with regulatory requirements.

Maintaining Documentation and Compliance:

  • Maintain organized records of all validation protocols, raw data, reports, and related documentation.
  • Ensure that all method validation activities are performed in compliance with relevant Standard Operating Procedures (SOPs), GLP, and regulatory guidelines.
  • Participate in internal and external audits related to method validation.
  • Contribute to the development and revision of QC procedures and method validation guidelines.

Job Type: Full-time

Pay: ₹15, ₹23,000.00 per month

Benefits:

  • Provident Fund

Work Location: In person

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