Quality Control Executive
13 hours ago
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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