Executive - Aseptic Area Supervisor

Role & responsibilities

• To perform all the activities outlined in SOP.
• Follow online documentation as per Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Responsible for producing Quality drug Product.
• To maintain personnel hygiene and discipline and area gowning procedure.
• To monitor and keep all equipment/ instruments in validated and calibrated state.
• To follow the written procedures and understood the materials transfer philosophy,

• To maintain the discipline in the department & Co- ordination with cross functional team members.
• Preparation and review of DQ, IQ, OQ and PQ of all the manufacturing equipment.
• Coordinate with MS&T for product transfer and execution of scale up and registration batches.
• To execute the Autoclave, Manufacturing and filling related activities.
• Preparation of SOPs and other master documents of production.
• To prepare and review trends, URS and QRM documents.
• To participate in production equipment Installation, Commissioning and Qualification activities.
• To conduct FAT and SAT of production equipment.
• To execute Scale-Up, Exhibit, Commercial and Engineering run Batches.
• Responsible to ensure that all equipment and lines are in qualified state.
• Audit Compliance
• Handling of regulatory audit