QC Executive

Position

Senior Officer – Quality Control (QC)

Department

Quality Control

Industry

Pharmaceutical Formulation Manufacturing

Reporting To

QC Manager / Head – Quality Control

Job Purpose

The Senior Officer – Quality Control is responsible for ensuring the testing, analysis, documentation, and release-related quality control activities of raw materials, in-process samples, finished products, stability samples, and other laboratory samples in compliance with approved specifications, SOPs, GMP, and regulatory requirements.

Key Responsibilities1. Sampling and Analysis

• Perform and supervise analysis of raw materials, packing materials, in-process samples, finished products, and stability samples.
• Conduct chemical and instrumental analysis as per approved specifications, STPs, and SOPs.
• Review analytical data and ensure accuracy, completeness, and compliance.

2. Instrument Handling

• Operate and ensure proper handling of laboratory instruments such as:
• HPLC
• UV-Visible Spectrophotometer
• FTIR
• Dissolution Apparatus
• Disintegration Test Apparatus
• pH Meter
• Analytical Balance
• Other QC laboratory equipment
• Ensure calibration, verification, and maintenance activities are performed as per the approved schedule.

3. Documentation

• Review and maintain analytical worksheets, logbooks, instrument usage records, and laboratory documentation.
• Ensure compliance with GDP, GMP, and data integrity requirements.
• Review COAs, analytical reports, and test results before submission to the QC Manager.

4. OOS / OOT / Deviations

• Participate in the investigation of OOS, OOT, deviations, incidents, and laboratory errors.
• Support implementation of CAPA and effectiveness checks.
• Ensure proper documentation and timely closure of investigations.

5. Stability and Method Activities

• Perform and review stability sample analysis as per the stability protocol.
• Assist in analytical method verification, validation, and transfer activities when required.

6. Team Supervision

• Guide and supervise QC Officers, Junior Officers, and Analysts.
• Ensure proper allocation of daily laboratory activities.
• Provide training to team members on SOPs, analytical procedures, GMP, and laboratory practices.

7. Compliance and Audit Support

• Ensure the QC laboratory complies with approved SOPs, GMP, GLP, and regulatory requirements.
• Support internal audits, customer audits, and regulatory inspections.
• Ensure laboratory readiness and timely completion of audit observations.

Educational Qualification

B.Pharm / M.Pharm / B.Sc. / M.Sc. in Chemistry or a relevant discipline

Experience

5–8 years of experience in the Quality Control Department of a pharmaceutical formulation manufacturing plant.

Required Skills

• Strong knowledge of GMP, GLP, GDP, and Data Integrity.
• Hands-on experience with analytical instruments, especially HPLC and UV.
• Knowledge of pharmaceutical formulation testing and documentation.
• Experience in handling investigations, OOS/OOT, deviations, and CAPA.
• Good leadership, communication, and team management skills.
• Ability to review analytical data and laboratory documentation.

Key Performance Indicators (KPIs)

• Timely completion of testing and analysis.
• Accuracy and compliance of analytical documentation.
• Timely closure of OOS/OOT, deviations, and CAPA.
• Instrument calibration and maintenance compliance.
• Audit readiness and regulatory compliance.
• Effective supervision and training of QC team members.

Work Location: Sachin, Surat, Gujarat

Pay: ₹25,000.00 - ₹47,000.00 per month

Benefits:

• Paid sick time
• Provident Fund

Work Location: In person