Quality Control Executive

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: ₹15,000.00 - ₹23,000.00 per month

Benefits:

• Provident Fund

Work Location: In person