Production Associate
CurrentIn my role within the Drug Substance Department, I've had the privilege of leading insulin purification endeavors utilizing cutting-edge HPLC techniques. With an unwavering commitment to excellence, I ensured every step adhered to stringent GMP and ALCOA standards, safeguarding both product quality and regulatory compliance.Collaboration has been at the heart of my approach, as I've worked closely with cross-functional teams to optimize production schedules and streamline unit operations. Through meticulous coordination of equipment maintenance and rigorous review of Batch Manufacturing Records, I've upheld the highest standards of quality assurance, ensuring every product meets or exceeds expectations.Responsibilities: • Led insulin purification using HPLC techniques in Drug Substance Department, ensuring GMP and ALCOA compliance.• Collaborated on production schedules, optimizing unit operations.• Coordinated equipment maintenance per SOPs in the production area.• Conducted thorough reviews of Batch Manufacturing Records for QA compliance.• Developed and maintained meticulous process documentation in Buffer Preparation Area.• Engaged in EHS programs, contributing to plant safety.• Executed protocols for equipment qualification and validation.• Formulated and revised SOPs for process modifications and improvements.Achievements:• Pioneered consecutive insulin purification batches with effective shift planning.• Implemented and refined HPLC methods, resulting in a remarkable 60% increase in the final API unloaded.• Collaborated on introducing an innovative inline buffer dilution skid, reducing TAT for HPLC regeneration.• Earned the 'Certificate of Commendation' for exceptional Q3 FY’23 contributions