Quality Control Executive

Job Description: QC Executive

Company: Alembic Ltd. (Alembic Group of Companies)

Department: Quality Control

Location: Gorwa, Vadodara

Position: Executive Quality Control

Position Overview

The QC Executive will be responsible for performing analytical testing of raw materials, inprocess samples, finished products, and stability samples in compliance with Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP). The role requires handson experience with analytical instruments such as HPLC, GC, FTIR, and UVVisible Spectrophotometer, as well as knowledge of OOS (Out of Specification) investigations and laboratory incident handling. The ideal candidate will ensure adherence to quality standards and contribute to maintaining a compliant, safe, and efficient laboratory environment.

Key Responsibilities

1. Analytical Testing & Instrument Operation

• Perform routine and nonroutine analysis of raw materials, intermediates, finished products, and stability samples.
• Operate and maintain analytical instruments including:
• HPLC (High-Performance Liquid Chromatography)
• GC (Gas Chromatography)
• FTIR (Fourier Transform Infrared Spectroscopy)
• UVVisible Spectrophotometer
• Ensure accurate documentation of test results in compliance with ALCOA+ principles.

2. Compliance & Laboratory Practices

• Follow Good Laboratory Practices (GLP) and cGMP guidelines in daytoday operations.
• Maintain updated records, logbooks, instrument usage logs, and analytical worksheets.
• Support implementation of quality systems and adherence to SOPs, guidelines, and regulatory requirements.

3. OOS, OOT & Laboratory Incident Handling

• Participate in OOS (Out of Specification) investigations, ensuring timely initiation, rootcause analysis, and documentation.
• Assist in handling OOT (Out of Trend) results and deviations as per approved procedures.
• Report and support investigations of laboratory incidents, instrument malfunctions, and nonconformities.

4. Instrument Calibration & Maintenance

• Perform daily checks, calibrations, and preventive maintenance of analytical instruments.
• Ensure timely coordination with service engineers for breakdowns or troubleshooting when required.
• Maintain calibration and maintenance records as per regulatory expectations.

5. Documentation & Reporting

• Prepare analytical reports, certificates of analysis (CoA), and documentation for regulatory audits.
• Ensure data integrity and compliance with ALCOA+ principles in all QC documentation.
• Review and update SOPs related to laboratory activities, as needed.

6. Audit Support

• Participate in internal and external (regulatory/customer) audits.
• Ensure area readiness and provide required documentation during inspections.

Required Skills & Competencies

• Handson experience with HPLC, GC, FTIR, UVVis Spectrophotometer.
• Strong understanding of GLP, cGMP, and quality system principles.
• Knowledge of OOS, OOT investigations, deviations, and laboratory incident handling.
• Good understanding of SOPs, validation requirements, and analytical workflows.
• Strong documentation and data integrity practices.
• Ability to troubleshoot analytical issues and instrument performance.
• Good communication, teamwork, and problemsolving skills.

Qualifications & Experience

• B.Sc / M.Sc (Chemistry or related field).
• 25 years of experience in Quality Control within the pharmaceutical industry (API/Formulation).
• Experience in a regulated environment (USFDA, MHRA, WHOGMP, etc.) is an added advantage.