Candidate should have Pharma API company background Conduct routine and non-routine analysis of raw materials, intermediates, and finished products using analytical instruments (HPLC, GC, UV-Vis, FTIR, etc.). Perform method development, method validation, and stability studies as per ICH guidelines. Operate and maintain analytical instruments and ensure proper calibration and documentation. Prepare and review analytical documents such as protocols, reports, and SOPs. Ensure compliance with GMP/GLP and regulatory requirements. Investigate out-of-specification (OOS) and out-of-trend (OOT) results and support root cause analysis. Coordinate with cross-functional teams for timely project execution.
Roles and Responsibilities Responsible for execution of multi-step synthetic routes, literature search, analysis of in-process/ products, isolation and purification of intermediates/ products. Candidates are expected to analyze reactions / products using various characterization techniques and interpretations of same. Responsible for process optimization, scale up of organic compounds from lab grams scale to kilograms scale. Desired Candidate Profile Good knowledge in synthetic chemistry, reaction mechanisms, expertise in literature search using various databases, design of synthetic routes, multi-step synthesis, costing of processes. Knowledge in characterization of reactants, reactions, products and interpretation using chromatographic techniques like HPLC, TLC, GC, MS, NMR, FTIR, Handling of air and moisture sensitive chemicals & reactions. Knowledge in isolation and purification techniques of organic compounds like distillation, crystallization, chromatographic techniques.
Bulk Drug, API Production. SOPs, cGMP, Reactor, BMR Review, Raw Material Hydrogenation, batch production Key member of troubleshooting the production of an FDA license product In process checking on various intermediate steps Developing new production methods or improving existing ones to increase efficiency or quality of product maintenance and repairs of equipment used in production processes Active calculation batch reconciliation on various stages To be responsible for Batch start up activity, monitoring, calibration of balance and other instruction given by the Superior. To review technical documents like batch records, cleaning records, validation protocols, cleaning verification protocols. To be responsible for receiving raw materials to delivering the finished products. Conducting chemical analyses of new products to ensure that they meet safety standards Preparing and review of various document regarding manufacturing like SOP, Batch production records, Reconciliation record Preparation of daily production report Prepare safety manuals for operator, Provide training to operator for plant operation Monitoring of Preventive maintenance schedule and planning. Bulk Drug, API Production- High Potency Experience (Oncology) Isolator Handling Isolator cleaning Packing Oncology Product Documentation of Oncology Product SOPs, cGMP, Reactor, BMR Review, Raw Material Hydrogenation, batch production Key member of troubleshooting the production of an FDA license product In process checking on various intermediate steps Developing new production methods or improving existing ones to increase efficiency or quality of product
1. System Operation: Monitor and operate water generation and distribution systems (RO, EDI, WFI, pre-treatment systems, storage tanks, and distribution loops). 2. Preventive Maintenance: Perform and document routine maintenance and sanitization of water systems as per SOPs. 3. Compliance & Documentation: Ensure all water system activities comply with GMP and regulatory standards. Maintain accurate logs, calibration records, and operational data. 4. Monitoring & Troubleshooting: Track key parameters (conductivity, TOC, microbial count, temperature, flow, pressure) and take corrective action in case of deviations. 5. Quality Support: Coordinate with the Quality Assurance and Quality Control departments for water sampling, validation, and trending reports. 6. Audit Preparedness: Support readiness for internal and external audits (e.g., FDA, WHO, EU-GMP) by maintaining all necessary documentation and logs. 7. Continuous Improvement: Recommend and implement improvements for water system reliability, efficiency, and compliance. 8. Team Mentoring: Guide and train junior operators and technicians on operational best practices and safety procedures.
Project Delivery Synthesis of different organic molecules based on customer requirement on different scale. ( From mg to gram ) Prepare review and present weekly updates, presentations To guide new chemist for efficient delivery of projects To search literature and design ROS for any given molecule. To characterise the molecule based on different spectroscopic technique. Perform purification of molecule by different technique such as Chromatography/ crystallisation. Improve Process for Scale up Troubleshoot and optimize reaction conditions actively participate in discussions and present results in weekly chemistry meetings Write-up experimental results and prepare chemistry presentations
Accounting Duties: • Assist in preparing financial statements, GST returns, TDS filings, and other statutory compliances. • Support audit processes, both internal and external. • Maintain documentation for invoices, receipts, and other financial records. Liaisoning Duties: • Act as a point of contact with government authorities (GST, Income Tax, Municipal Corporation, etc.) and follow up on pending matters. • Coordinate with CA, consultants, and legal advisors for compliance, licensing, and taxation matters. • Ensure timely submission of required forms and documents to regulatory bodies. • Maintain good working relationships with vendors, banks, and contractors. • Handle inspections, renewals, and license applications.
1. Execute and monitor API manufacturing processes as per approved Batch Manufacturing Records (BMRs). 2. Supervise shift operations including manpower management and production output. 3. Ensure compliance with cGMP, safety, and EHS norms during operations. 4. Monitor critical process parameters and take corrective actions as needed. 5. Prepare and maintain production documentation BMR, logbooks, deviation reports, and incident reports. 6. Coordinate with QA, QC, Engineering, and Warehouse teams for smooth production flow. 7. Support validation and technology transfer activities. 8. Ensure timely availability of raw materials, solvents, and packing materials. 9. Participate in internal and external audits (USFDA, WHO-GMP, etc.). Identify areas of improvement for yield, efficiency, and process optimization
Accounting Duties: • Assist in preparing financial statements, GST returns, TDS filings, and other statutory compliances. • Support audit processes, both internal and external. • Maintain documentation for invoices, receipts, and other financial records. Liaisoning Duties: • Act as a point of contact with government authorities (GST, Income Tax, Municipal Corporation, etc.) and follow up on pending matters. • Coordinate with CA, consultants, and legal advisors for compliance, licensing, and taxation matters. • Ensure timely submission of required forms and documents to regulatory bodies. • Maintain good working relationships with vendors, banks, and contractors. • Handle inspections, renewals, and license applications.
Candidate should have Pharma API or Chemical company background Receive, inspect, and verify raw materials, packaging materials, and other incoming goods as per SOPs. Maintain proper storage of materials following FIFO/FEFO and GMP guidelines. Ensure all materials are stored in appropriate environmental conditions (temperature, humidity, etc.). Maintain inventory records using ERP systems. Prepare and maintain GMP-compliant documentation: GRNs, stock registers, logbooks, issuance records, etc. Coordinate with Quality Control and QA for sampling and clearance of received goods. Dispense raw materials and packaging materials as per batch production requirements. Monitor and control warehouse hygiene, pest control, and housekeeping activities. Ensure compliance with safety regulations, EHS norms, and GMP requirements at all times. Participate in internal and external audits and assist in the implementation of CAPAs. Conduct periodic stock audits and cycle counts. Train and supervise warehouse helpers and staff. Preferred candidate profile Transportaion Health Insurance
Supervise and execute routine microbiological testing of raw materials, APIs, water, environmental monitoring, and personnel hygiene. Oversee the qualification, calibration, and maintenance of microbiology lab equipment (e.g., autoclaves, incubators, LAFs, particle counters). Review and approve microbial test reports and ensure timely release of results. Manage environmental monitoring programs (cleanroom, gowning areas, etc.) including alert/action limit trending. Monitor and trend data for microbial limits, endotoxin, bioburden, and water system testing (WFI, purified water, etc.). Conduct microbiological validations and qualifications including method validations, media fill (aseptic process simulation), disinfectant efficacy studies, and microbial identification. Handle and investigate out-of-specification (OOS), deviation, and non-conformance reports related to microbiological testing. Maintain GMP documentation – SOPs, STPs, protocols, reports, logbooks. Support regulatory audits (USFDA, MHRA, WHO, etc.) and customer inspections Compliance: Ensure all microbiological practices comply with cGMP, GLP, ICH, and regulatory standards. Equipment Handling: Operate, calibrate, and maintain microbiological instruments like Laminar Air Flow, Incubators, Autoclaves, Colony Counters, and Sterility Isolators. Train and mentor junior microbiologists and ensure adherence to lab safety and compliance practices. Audit Readiness: Support internal and external audits by maintaining proper documentation and following quality practices. Coordination: Collaborate with QA, Production, and Engineering teams for deviation investigations, CAPAs, and change controls involving microbiological aspects.