To perform In -Process Quality Assurance activities in production during manufacturing and packing of product. To store, upkeep, visual inspection and destruction of control samples. To withdraw samples at different stages of In-Process material finished as well as validation samples as per TD, protocol and submission to QC lab. To prepare validation planner for different equipment's. Preparation, execution and compilation as per process validation protocols & reports. Preparation of process optimization protocols and compilation of process optimization reports. Preparation of hold time study protocols and compilation of hold time study monitoring reports. Preparation & review of cleaning validation protocols and compilation of cleaning validation reports. Preparation & review of allergen validation protocols and compilation of allergen validation reports. To prepare and review of validation related SOPs and compliance of them. To review Technical Direction with respect to Equipment and their critical process variables. Preparation, execution, and review of equipment qualification, requalification protocols and compilation reports. To prepare annual equipment qualification planner with respect to validation master plan. To prepare, review of HVAC qualification/re-qualification protocol and report. BMR/BPR Issuance to Plant. To compile and review of different equipment's and utilities life cycle report. Preparation of protocols for qualifications of newly procured equipment's and of equipment's transferred from other location. Preparation of Validation Master Plan and Site Master File Preparation of BMR and BPR with reference to the technical direction for all product. Finished Good Release To perform any other works as and when assigned by department Head
