Quality Control Executive

15 hours ago

Salem, India Cologenesis Healthcare Pvt Ltd Full time

**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.

Pay: ₹15,000.00 - ₹23,000.00 per month

**Benefits**:

- Provident Fund

Schedule:

- Day shift

Work Location: In person

Expected Start Date: 02/05/2025

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