Role & responsibilities Responsible for Drug Master Filing submissions to various regulatory agencies like USFDA, European Agencies, Brazil, and other semi-regulatory countries. Review and submission of Response to queries raised on DMF by USFDA, and other agencies. Review and submission of Amendments and revisions of Drug Master Files. Review and ensuring the regulatory compliance of CMC information and manufacturing facilities of advanced intermediated through regular visits, which are intended to submit to regulatory markets. Evaluation of cost reductions processes in regulatory point of view and submitting to different regulatory agencies. Review of OOS, BPR, process validation, and other quality assurance documents required for regulatory submissions. Markets Handled: USA, Europe, Canada, Brazil, other ROW etc. Preferred Candidate Candidate must have experience working in Regulatory Affairs in Pharma API Industry.
Role & responsibilities Experience in Synthesis and Development in API R&D. To develop cost effective, high quality and minimum environmental hazardous process considering ICH guideline. To finalize the route of synthesis after doing feasibility study of ROS to develop process for DMF filing. Lab process development and its optimization with control strategy and Lab validation experience of at least 3-5 products. Should be able to design, finalize and propose specification of KSM, Intermediates and finish API as per developed control strategy. Should have exposure for transfer the technology to pilot plant and PD Lab. Should able to prepare the documents for Process development report and technology transfer. Should be well aware of characterization like NMR, Mass, IR etc. Literature survey and have trouble shooting ability of plant and Lab scale synthesis, impurity problems.
Role & responsibilities Follow cGMP and regulatory standards to maintain product quality and efficiency. Oversee batch initiation and monitor production processes to ensure compliance with SOPs and specifications . Calibrate balances and other critical instruments, ensuring accurate measurements and documentation. Verify and review Batch Records (BR), Batch Manufacturing Records (BMR), SOPs, and validation protocols for accuracy. Work with QA, QC, and maintenance teams to ensure smooth operations and resolve issues. Prepare and maintain accurate production reports and documentation. Preferred candidate profile M.Sc. in Organic Chemistry / B.Tech Chemical Engineering. 2 to 7 years of experience in Production within the API industry. Strong understanding of GMP, documentation review, troubleshooting, and collaboration with cross-functional teams.
Role & responsibilities Maintaining, calibrating, and troublesh instrumentation and control systems. Preparation of SOPs, DQ, IQ, OQ, and a documentation. Perform preventive and corrective main mechanical equipment. Ensuring minimal downtime, and adher and compliance standards. Must have strong troubleshooting skills experience with GMP practices and documentation. Operation & maintenance of utilities: boilers,chillers, compressors, HVAC
Role & responsibilities 1. Development of Analytical methods. 2. Validation of Analytical methods. 3. Preparing analytical method development reports. 4. Literature survey for existing analytical methods. 5. Carry out literature survey by establishing the strategies. 6. Maintenance of FDA department. 7. Coordinating various development activities in FDA laboratory. 8. Maintenance of reference standard, working standards and their standardization. 9. Co-ordinating the activities in Chemical and Instrumentation. 10. Analytical Method Development and handling of Troubleshooting. Preferred candidate profile M.Sc. - Analytical / Organic Chemistry Candidate from Vadodara or nearby location preferred
Role & responsibilities R&D Synthesis: Experience in API synthesis, process development, and DMF filing. Develop cost-effective, high-quality, and eco-friendly processes as per ICH guidelines. Optimize lab processes, validate products, and transfer technology to pilot plant. Design and propose specifications for KSM, intermediates, and APIs. Proficient in NMR, Mass, IR characterization and troubleshooting synthesis/impurity issues. Prepare documentation for process development and technology transfer. ADL: Method Development by HPLC. Method Validation by HPLC. Preparation, Review, and Technical input for specification and method of analysis. Experience in GLP related activities i.e., calibration, qualification of instruments and standard management.
Role & responsibilities Ensure compliance with cGMP, regulatory, and internal quality standards. Manage QMS activities deviations, change controls, CAPA, OOS/OOT, document control, etc. Handle Analytical Quality Assurance (AQA) activities data review, audit readiness, and compliance monitoring. Oversee In-process Quality Assurance (IPQA) – batch manufacturing records review, shop floor monitoring, line clearance, process compliance. Conduct internal audits, support external audits (regulatory and customer), and ensure timely closure of audit observations. Drive new initiatives in digitalization, automation, and process improvement in QA systems. Training and mentoring of team members to strengthen quality culture. Preferred candidate profile B.Pharm / M.Pharm / M.Sc. (Chemistry) with 4 – 15 years’ experience in QA in API Pharma industry. Strong knowledge of AQA, QMS, IPQA, documentation, and regulatory compliance . Hands-on experience in handling audits (USFDA, EU, WHO, etc.).
FIND ON MAP