Oversee aseptic manufacturing processes, including formulation, filtration, filling, and lyophilization, ensuring strict adherence to cGMP guidelines and cleanroom protocols.
Review and manage critical documentation, such as Batch Manufacturing Records (BMRs) and Standard Operating Procedures (SOPs), to guarantee real-time data integrity and regulatory compliance.
Investigate production deviations and implement Corrective and Preventive Actions (CAPAs) in collaboration with Quality Assurance to maintain product sterility and resolve operational issues.
Train and supervise shop-floor operators on proper cleanroom behavior, advanced aseptic techniques, and equipment operation to maximize efficiency and minimize contamination risks.