Shift Chemist QA QC Nandesari

The Quality Control Analyst is responsible for ensuring the accuracy, reliability, and compliance of laboratory testing and documentation processes. The role involves performing instrumental analysis, monitoring product quality, maintaining laboratory equipment, managing laboratory documentation, and ensuring adherence to Good Laboratory Practices (GLP), Good Documentation Practices (GDP), ISO standards, and regulatory requirements.

Key Responsibilities:

1. Sample Analysis

• Perform routine and non-routine testing of raw materials, intermediates, and finished products using approved analytical methods.
• Prepare and standardize volumetric solutions, reagents, and laboratory chemicals.
• Ensure accurate and timely completion of analytical testing activities.

2. Quality Control Monitoring

• Monitor product quality during shifts and ensure compliance with established specifications and quality standards.
• Identify and investigate out-of-specification (OOS) or abnormal analytical results.

3. Instrument Operation & Maintenance

• Operate, calibrate, troubleshoot, and maintain laboratory instruments including:
• Spectrometers
• Analytical Balances
• pH Meters
• Other analytical laboratory equipment
• Conduct daily, monthly, and periodic calibrations as per approved schedules.
• Ensure preventive maintenance activities are completed and documented.

4. Documentation & Data Management

• Record analytical data accurately and maintain laboratory documentation in compliance with GDP requirements.
• Prepare, review, and maintain test reports, SOPs, STPs, and laboratory records.
• Enter and manage testing data in the Laboratory Information Management System (LIMS).

5. Compliance & Quality Assurance

• Ensure compliance with GLP, GDP, ISO standards, and internal quality procedures.
• Participate in laboratory audits, inspections, and continuous improvement initiatives.
• Maintain a safe and organized laboratory environment.

6. Communication & Reporting

• Effectively communicate analytical results and quality-related observations to relevant departments.
• Support cross-functional teams with laboratory data and technical information.

7. Emergency & Incident Handling

• Respond promptly to equipment failures, abnormal test results, safety incidents, and other laboratory emergencies.
• Escalate critical issues and support root cause investigations and corrective actions.

Required Qualifications:

• Bachelor's or Master's Degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related discipline.
• Experience in Quality Control, Analytical Laboratory Operations, or Testing Laboratories.
• Knowledge of GLP, GDP, ISO standards, and laboratory quality systems.
• Familiarity with LIMS and analytical instrumentation.