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: ₹15,000.00 - ₹23,000.00 per month
Benefits:
Provident Fund
Work Location: In person
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