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
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
Job Summary: The Granulation Operator is responsible for carrying out all granulation activities as per approved batch manufacturing records (BMR) and standard operating procedures (SOPs). The role ensures the preparation of high-quality granules for tablet compression, maintaining compliance with cGMP, safety, and quality standards. Key Responsibilities: Operate granulation equipment such as: High-Shear Mixer/Granulator Fluid Bed Processor (FBP/FBD) Multi-mill, Sifter, Blender, and other ancillary machines Execute granulation process steps including dry mixing, wet granulation, drying, milling, and blending as per BMR instructions. Monitor critical process parameters (temperature, time, air flow, and moisture content) and record them accurately. Ensure line clearance before starting the batch and verify material identity and quantity. Maintain cleanliness and GMP compliance in the granulation area. Perform in-process checks (e.g., loss on drying (LOD), sieve analysis, bulk density) and report any deviations or abnormalities. Assist in equipment changeover, cleaning, and preventive maintenance activities. Follow all SOPs, safety norms, and EHS guidelines during operation. Maintain batch records, equipment usage logs, and cleaning records accurately. Report any equipment malfunction or process deviation to the Production Supervisor immediately. Participate in training programs to enhance process and quality knowledge. Job Types: Full-time, Permanent Pay: ₹8,000.00 - ₹12,000.00 per month Work Location: In person
Job Summary: The QC Lab Assistant is responsible for assisting in sampling, testing, and documentation of raw materials, in-process samples, finished products, and stability samples as per approved specifications and standard operating procedures (SOPs). The role ensures compliance with cGMP, GLP, and data integrity standards to maintain consistent product quality. Key Responsibilities: Sample Handling & Preparation: Receive, label, and log samples of raw materials, in-process materials, intermediates, and finished products. Prepare samples and standard solutions for analysis under supervision. Testing Support: Assist QC Analysts in performing routine physical, chemical, and instrumental analysis (e.g., pH, loss on drying, identification tests, etc.). Support in operation of analytical instruments such as HPLC, UV-Vis Spectrophotometer, FTIR, and Dissolution Tester (if trained). Conduct basic wet chemistry tests as per SOPs. Documentation: Maintain test records, sample registers, logbooks, and analytical reports accurately and neatly. Ensure data integrity and compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, etc.). Housekeeping & Compliance: Maintain cleanliness of the laboratory, workbenches, and instruments. Ensure proper labeling and segregation of samples and reagents. Follow all Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and safety procedures. Instrument Maintenance: Clean and calibrate laboratory equipment under supervision. Record equipment usage and maintenance in logbooks. Sampling Activities: Support sampling of raw materials, packaging materials, and finished products as per standard protocols. Training & Development: Participate in on-the-job training programs related to quality systems, documentation, and analytical techniques. Job Types: Full-time, Permanent, Fresher Pay: ₹8,000.00 - ₹15,000.00 per month Work Location: In person
Job Summary: The QC Lab Assistant is responsible for assisting in sampling, testing, and documentation of raw materials, in-process samples, finished products, and stability samples as per approved specifications and standard operating procedures (SOPs). The role ensures compliance with cGMP, GLP, and data integrity standards to maintain consistent product quality. Key Responsibilities: Sample Handling & Preparation: Receive, label, and log samples of raw materials, in-process materials, intermediates, and finished products. Prepare samples and standard solutions for analysis under supervision. Testing Support: Assist QC Analysts in performing routine physical, chemical, and instrumental analysis (e.g., pH, loss on drying, identification tests, etc.). Support in operation of analytical instruments such as HPLC, UV-Vis Spectrophotometer, FTIR, and Dissolution Tester (if trained). Conduct basic wet chemistry tests as per SOPs. Documentation: Maintain test records, sample registers, logbooks, and analytical reports accurately and neatly. Ensure data integrity and compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, etc.). Housekeeping & Compliance: Maintain cleanliness of the laboratory, workbenches, and instruments. Ensure proper labeling and segregation of samples and reagents. Follow all Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and safety procedures. Instrument Maintenance: Clean and calibrate laboratory equipment under supervision. Record equipment usage and maintenance in logbooks. Sampling Activities: Support sampling of raw materials, packaging materials, and finished products as per standard protocols. Training & Development: Participate in on-the-job training programs related to quality systems, documentation, and analytical techniques. Job Types: Full-time, Permanent, Fresher Pay: ₹8,000.00 - ₹15,000.00 per month Work Location: In person
Job Summary: The Granulation Operator is responsible for carrying out all granulation activities as per approved batch manufacturing records (BMR) and standard operating procedures (SOPs). The role ensures the preparation of high-quality granules for tablet compression, maintaining compliance with cGMP, safety, and quality standards. Key Responsibilities: Operate granulation equipment such as: High-Shear Mixer/Granulator Fluid Bed Processor (FBP/FBD) Multi-mill, Sifter, Blender, and other ancillary machines Execute granulation process steps including dry mixing, wet granulation, drying, milling, and blending as per BMR instructions. Monitor critical process parameters (temperature, time, air flow, and moisture content) and record them accurately. Ensure line clearance before starting the batch and verify material identity and quantity. Maintain cleanliness and GMP compliance in the granulation area. Perform in-process checks (e.g., loss on drying (LOD), sieve analysis, bulk density) and report any deviations or abnormalities. Assist in equipment changeover, cleaning, and preventive maintenance activities. Follow all SOPs, safety norms, and EHS guidelines during operation. Maintain batch records, equipment usage logs, and cleaning records accurately. Report any equipment malfunction or process deviation to the Production Supervisor immediately. Participate in training programs to enhance process and quality knowledge. Job Types: Full-time, Permanent Pay: ₹8,000.00 - ₹12,000.00 per month Work Location: In person