Production Chemist

Job Summary

The Approved Chemist is responsible for ensuring that all analytical, manufacturing, and documentation activities in the pharmaceutical facility comply with regulatory standards (as per Drugs and Cosmetics Act & Rules). The role includes supervision of laboratory and production activities, planning of daily testing and release schedules, and ensuring adherence to cGMP, GLP, and company quality policies.

Key Responsibilities1. Analytical & Testing Responsibilities

• Conduct and approve testing of raw materials, intermediates, and finished products as per approved specifications.
• Ensure all instruments are calibrated, validated, and maintained as per SOPs.
• Review and sign analytical reports, COAs, and stability data before batch release.
• Ensure proper documentation, data integrity, and compliance with cGMP norms.
• Maintain analytical records and ensure timely reporting of out-of-specification (OOS) or out-of-trend (OOT) results.

2. Supervision Responsibilities

• Supervise the work of QC analysts, chemists, and production operators to ensure compliance with approved procedures.
• Guide team members on analytical methods, troubleshooting, and documentation practices.
• Ensure safety protocols, proper gowning, and hygiene practices are followed in the lab and production area.
• Conduct training sessions for new chemists and technicians on testing methods, documentation, and regulatory practices.

3. Planning & Coordination

• Plan and schedule daily testing activities for raw materials, intermediates, and finished products to meet production timelines.
• Coordinate with production, QA, and warehouse departments for smooth material release and batch clearance.
• Ensure timely calibration of instruments and preventive maintenance schedules.
• Assist in planning resources, manpower, and analytical workloads for efficient lab operations.

4. Documentation & Compliance

• Review, verify, and approve analytical documents, logbooks, and test reports.
• Ensure all records are maintained as per regulatory requirements and ready for audits.
• Participate in internal and external audits (GMP, WHO, ISO, CDSCO, FDA, etc.) and assist in CAPA implementation.
• Ensure all testing and approval procedures are in accordance with the Drugs & Cosmetics Act and company’s product licenses.

5. Continuous Improvement

• Identify process improvements to enhance efficiency and reduce testing turnaround time.
• Implement best practices in analytical testing, documentation, and safety management.
• Stay updated on pharmacopeial changes (IP, BP, USP, EP) and regulatory updates affecting analytical procedures.

Qualifications & Experience

• Education: B.Pharm / M.Pharm / M.Sc. (Chemistry)
• Regulatory Requirement: Approved Chemist license from State Drug Control Department (Form 39 or equivalent).
• Experience: 3–8 years in Quality Control / QA in a pharmaceutical manufacturing unit.
• Knowledge: cGMP, GLP, Analytical Techniques (HPLC, GC, UV, IR), Regulatory Guidelines, and Documentation Practices.

Key Skills

• Strong analytical and problem-solving skills.
• Excellent supervision and team coordination abilities.
• In-depth understanding of pharmaceutical testing standards and documentation.
• Good communication and report preparation skills.
• Proficiency with LIMS / ERP systems (preferred).

Job Type: Full-time

Pay: ₹10,184.14 - ₹45,000.00 per month

Work Location: In person