01 Aug
|
Selective Placement Consultants
|
Bhiwadi
01 Aug
Selective Placement Consultants
Bhiwadi
Job Description:
Aseptic Processing: Overseeing and executing the manufacturing of APIs in a sterile workplace, including compounding, filtration, and filling operations, while strictly adhering to aseptic techniques.
cGMP Compliance: Ensuring all production activities comply with current Valuable 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 setting, 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.
📌 Production Sterile Bhiwadi
🏢 Selective Placement Consultants
📍 Bhiwadi