Azico Biophore India Pvt Ltd

Role & responsibilities : Lead the sterile API production operations , ensuring all activities align with production schedules and adhere to GMP requirements. Ensure the proper execution of Microbial Limit Tests (MLT) and Bacterial Endotoxin Tests (BET) as part of in-process control and finished product release. Provide technical leadership and troubleshoot any challenges during production to ensure sterile conditions are maintained throughout manufacturing. Implement and manage sterilization processes , including the use of autoclaves and other sterilization equipment, ensuring all systems are validated and functioning optimally. Oversee the execution and analysis of environmental monitoring for contamination control and cleanroom maintenance . Review and approve SOPs, batch records , and technical documentation for sterile operations and testing. Collaborate with Quality Assurance (QA) and Quality Control (QC) teams to resolve any deviations, CAPAs, or issues related to sterility or endotoxin failures . Maintain continuous training programs for the production team on MLT/BET protocols , regulatory updates, and aseptic techniques. Act as a subject matter expert and provide guidance to cross-functional teams on sterile manufacturing practices and testing requirements. Continuously evaluate and improve production efficiencies through lean manufacturing principles and process optimization. Manage compliance with regulatory standards (FDA, EMA, WHO, etc.), ensuring full inspection readiness and the ability to address regulatory concerns effectively. Skills & Competencies: In-depth experience in sterile API manufacturing and understanding of aseptic processing and cleanroom management . Strong knowledge and hands-on experience with MLT (Microbial Limit Testing) and BET (Bacterial Endotoxin Testing) . Deep understanding of GMP, GLP , and regulatory guidelines governing pharmaceutical manufacturing. Experience in troubleshooting and resolving production issues related to sterility and endotoxin contamination. Leadership experience in managing production teams and cross-departmental collaboration. Proven track record in process optimization and driving continuous improvement initiatives. Strong ability to mentor and develop talent within the production department. Preferred Experience: Significant experience in leading sterile production operations for complex formulations or highly regulated products. Exposure to multi-site production and managing scale-up processes for sterile manufacturing. Expertise in regulatory inspections and quality audits (FDA, EMA, etc.). The Senior will oversee and manage the production processes within the sterile API manufacturing facility, ensuring optimal operations while maintaining a high standard of quality and compliance with regulatory standards. The role requires extensive knowledge in Microbial Limit Testing (MLT) , Bacterial Endotoxin Testing (BET) , and comprehensive experience in sterile process management . This person will lead production teams, drive process improvements, and ensure that all operations are carried out in accordance with GMP, SOPs, and international regulations. Why Join Us? Opportunity to lead in a state-of-the-art sterile API facility with cutting-edge technology. Competitive salary and benefits. Be part of a collaborative, quality-driven team focused on delivering life-changing medicines globally.