Job Purpose
The Senior will oversee and manage the production processes & multiple production blocks operations in the manufacturing facility, ensuring optimal operations while maintaining a high standard of quality and compliance with regulatory standards. The role requires extensive knowledge on end to end operations. 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.
Key Responsibilities
- Lead the API/Sterile API production operations, ensuring all activities align with production schedules and adhere to GMP requirements.
- Ensure the proper execution 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 from new technology to delivery, 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.
- 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
- Strong knowledge on trouble shoot, Scale up, Validations, Effluent management, Recovery solvent management
- Strong knowledge and hands-on experience to control the 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/training and develop talent within the production department.
Preferred Experience
- Significant experience in leading production multiple blocks 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.).
