Role & responsibilities
To perform all the activities outlined in SOP.
Follow online documentation as per Valuable Manufacturing Practices (GMP) and Valuable 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