The Production Chemist will be responsible for executing and monitoring API manufacturing processes, ensuring compliance with cGMP, SOPs, and regulatory guidelines . The role involves operating chemical process equipment, documentation, troubleshooting, and process optimization to achieve efficiency, safety, and quality standards. Key Responsibilities & Duties: Process Execution: Perform batch manufacturing activities in line with Standard Operating Procedures (SOPs), Batch Production Records (BPRs), and cGMP requirements. Equipment Operation: Operate and monitor reactors, centrifuges, multi-mill, shifter, tray dryer, filtration systems, GLR, and SSR equipment . Quality Assurance & Compliance: Coordinate with QA/QC teams for batch release, deviation handling, and ensure adherence to regulatory and quality standards . Documentation: Maintain accurate production records, logbooks, and deviation reports ensuring data integrity and audit readiness. EHS & Safety Compliance: Follow Environmental, Health & Safety (EHS) protocols, participate in safety drills, and ensure a safe work environment. Process Optimization: Assist in scale-up, yield improvement, and continuous improvement initiatives for cost-effective production. Troubleshooting & Maintenance: Identify and resolve equipment or process deviations in coordination with the engineering and maintenance teams . Shift Management: Supervise shift operations, allocate tasks, and ensure smooth production workflow. Qualifications & Experience Education: B.Sc./M.Sc. in Chemistry or B.E. in Chemical Engineering. Experience: 1 - 6 years in API production / pharmaceutical manufacturing . Technical Skills: Knowledge of GMP, GLP, ICH, and regulatory compliance . Hands-on experience with clean room operations, batch documentation, and shift planning . Familiarity with process safety, scale-up, and validation activities . Preferred Attributes Strong analytical, problem-solving, and decision-making skills . Ability to work effectively in a fast-paced, regulated production environment . Good communication, teamwork, and reporting skills . Flexible to work in shifts and handle multiple tasks.
We are seeking a highly skilled Executive / Sr. Executive Quality Assurance with 8 to 10 years of experience in API / Bulk Drug Manufacturing . The role involves overseeing laboratory incidents, OOS/OOT investigations, analytical method validations, data integrity compliance , and ensuring adherence to GMP and regulatory standards . Key Responsibilities: Handle and review laboratory incidents, OOS (Out of Specification), OOT (Out of Trend), deviations, and root cause investigations . Review and monitor calibration schedules and records for critical analytical instruments (HPLC, GC, UV, IR, AAS, ICP-MS). Oversee analytical method validation, method transfers, and specification reviews in alignment with regulatory requirements. Provide training to QC teams on laboratory procedures, data integrity , and documentation practices . Conduct surprise lab audits/visits and proactively identify compliance gaps to ensure readiness for inspections. Ensure compliance with cGMP, ICH, and regulatory guidelines throughout QA operations. Eligibility Criteria: Education: B.Sc / M.Sc in Chemistry or related field. Experience: Minimum 8 to 10 years in pharmaceutical Quality Assurance (API / Bulk Drug). Preferred Candidates: Male candidates available for immediate joining .
This role is responsible for technology transfer, process scale-up, equipment selection, and process validation in API manufacturing. The position ensures that the selected equipment aligns with process requirements, product quality, safety, and regulatory compliance, while supporting continuous improvement and operational excellence. Key Responsibilities: 1. Technology Transfer & Scale-up Lead the transfer of chemical processes from R&D to manufacturing. Evaluate and optimize process parameters for scale-up using mass and energy balances. Collaborate with Engineering for facility fitment, equipment readiness, and plant execution. 2. Equipment Selection & Sizing Analyse process requirements (reaction type, pressure/temperature profile, mixing, solvent use, etc.) to recommend suitable equipment. Select and size reactors, centrifuges, dryers, heat exchangers, condensers, and other equipment based on: Reaction kinetics and thermodynamics Process safety and control requirements Material compatibility and GMP compliance Evaluate batch vs. continuous processing options. Ensure scalability, containment, cleanability, and GMP compliance. Review P&IDs and layouts with Engineering and Production teams. 3. Process Optimization & Validation Conduct trials for equipment qualification and process optimization. Prepare and execute process validation protocols and reports. Lead QbD, DoE, and Process Analytical Technology (PAT) initiatives. 4. Documentation & Compliance Prepare/review equipment specifications, MFRs, BMRs, risk assessments, and validation documents. Ensure adherence to ICH Q8Q11, cGMP, USFDA, EUGMP, and other global guidelines. Support data generation for DMF filings and regulatory responses. 5. Cross-functional Collaboration Coordinate with R&D, QA, QC, Production, Engineering, EHS, and Regulatory Affairs. Provide technical training to operations and quality teams. Participate in internal/external audits and ensure compliance. 6. Continuous Improvement & Troubleshooting Analyse deviations and implement process/equipment modifications. Identify bottlenecks and recommend process/equipment upgrades. Drive cost-saving and productivity initiatives through efficient process/equipment utilization. Required Qualifications & Skills Education: B.E./B.Tech/M.Tech in Chemical Engineering or M.Sc. in Chemistry. Experience: 7 - 10 years in Technical Services, Process Engineering, or API Manufacturing. Strong understanding of process engineering and equipment design principles. Proven hands-on experience in selecting equipment for reactions, crystallization, drying, and filtration. Proficiency in PFDs, P&IDs, and risk mitigation strategies for scale-up. Working knowledge of process simulation tools (Aspen, ChemCAD, etc.) preferred. Familiarity with cGMP, regulatory requirements, and process safety norms.