Executive- Quality Control

Job Title: Quality Control Executive – Finished Product (Chemical Testing)

Department: Quality Control (QC)
Location: [Insert Location]
Reports to: QC Manager / Quality Head
Experience Required: 2–5 years in pharmaceutical/chemical industry
Qualification: B.Sc. / M.Sc. (Chemistry), B.Pharm / M.Pharm

Job Purpose:

Responsible for sampling and chemical analysis of finished pharmaceutical products, ensuring compliance with standard operating procedures (SOPs), regulatory standards (ICH), and internal quality specifications using techniques such as HPLC, UHPLC, GC, and wet chemistry.

Key Responsibilities:1. Sampling & Testing

• Perform sampling of finished products as per approved SOPs.
• Conduct chemical analysis using validated analytical methods (wet chemistry and instrumental methods like HPLC, UHPLC, GC).
• Ensure all tests are conducted in accordance with Analytical Data Sheets and test methods.

2. Documentation & Compliance

• Prepare and maintain test records, COAs (Certificate of Analysis), WRS (Working Reference Standards) logbooks, and Analytical Data Sheets.
• Maintain raw data and ensure timely review and approval of results.
• Adhere to ICH Q2/Q6 guidelines for method validation and product specifications.

3. Investigation & Reporting

• Handle OOS (Out of Specification) and OOC (Out of Trend) results, including root cause analysis, CAPA implementation, and documentation.
• Participate in Deviation, Change Control (DC), and Corrective/Preventive Actions (CAPA) processes.

4. Instrument Operation & Calibration

• Operate and troubleshoot HPLC, UHPLC, GC, UV, and other analytical instruments.
• Ensure instruments are calibrated and maintained as per AMC (Annual Maintenance Contract) schedules.

5. Stability & Regulatory Compliance

• Perform stability studies on finished products as per ICH guidelines and ensure timely reporting.
• Contribute to CSR (Comparative Study Report) and regulatory documentation when required.

6. Review & Audit

• Conduct peer reviews of analytical documents.
• Assist during internal and external audits (e.g., USFDA, WHO, MHRA).
• Ensure GMP and GLP compliance in the QC lab.

Required Skills:

• In-depth knowledge of analytical techniques (HPLC, GC, wet chemistry)
• Understanding of ICH guidelines, GMP/GLP, OOS/OOC handling
• Good documentation practices and data integrity awareness
• Proficient in analytical software (Empower, LabSolutions, Chromeleon preferred)

Job Types: Full-time, Permanent

Pay: ₹300,000.00 - ₹600,000.00 per year

Benefits:

• Food provided
• Health insurance
• Provident Fund