Production Sterile

Job Description:

• Aseptic Processing: 

  Overseeing and executing the manufacturing of APIs in a sterile environment, including compounding, filtration, and filling operations, while strictly adhering to aseptic techniques.
• cGMP Compliance: 

  Ensuring all production activities comply with current Good Manufacturing Practices (cGMP) and other relevant regulatory requirements (e.g., FDA, EMA).
• Documentation: 

  Accurate and timely completion and review of batch manufacturing records (BMRs), batch production records (BPRs), logbooks, and other critical documentation.
• Equipment Operation and Maintenance: 

  Operating, cleaning, and sanitizing sterile manufacturing equipment such as reactors, filters, sterilizers, and filling machines, and performing basic troubleshooting.
• Area Management: 

  Maintaining the cleanliness and sterility of classified areas (e.g., Grade A, B, C, D) through proper cleaning, sanitization, and environmental monitoring procedures, including fogging activities.
• Training and Development: 

  Providing on-the-job training to junior staff and technicians on sterile operations, cGMP, and safety protocols.
• Quality Control Coordination: 

  Collaborating with Quality Assurance (QA) and Quality Control (QC) departments for in-process checks, validation activities, and incident investigations.
• Material Handling: 

  Proper handling of raw materials, intermediates, and finished APIs within the sterile environment, including decartoning, weighing, and transfer.
• Safety Adherence: 

  Following all safety procedures and guidelines, including the use of personal protective equipment (PPE) and handling of hazardous materials.