Theragen Lifesciences Pvt Ltd

Role & responsibilities 1. Perform method development, validation, and routine analytical testing for APIs and formulations. 2. Operate, calibrate, and troubleshoot HPLC, UHPLC, and GC instruments independently. 3. Ensure all analytical activities comply with GMP, GLP, and relevant regulatory guidelines. 4. Prepare, review, and maintain analytical documents, including protocols, reports, and SOPs. 5. Critically evaluate analytical results, identify deviations, and implement effective corrective actions. 6. Support formulation, QA, and regulatory teams during development and dossier submission stages. 7. Maintain data integrity and documentation as per regulatory expectations (USFDA, EMA, MHRA, etc.). 8. Participate in internal and external audits and contribute to continuous improvement initiatives. Preferred candidate profile We are seeking a skilled and motivated AR&D Senior Executive with strong expertise in operating and troubleshooting analytical instruments such as HPLC, UHPLC, and GC. The candidate should have a solid background in analytical chemistry, method development and validation, and should be well-versed with GMP practices and regulatory expectations of US and Europe markets.