Jay Patel Email & Phone Number

Job Responsibility -Working with CGMP, GMP, and GDP. Working with SOP. -Preparation & records the test solution, volumetric solution, Indicator solution and Reagent solution. -Sampling of Water Samples, Raw Materials, Packing materials. -Analysis and reporting of Water Samples, Raw Materials, packing materials, In-process Sample, Finish Product, Stability Sample Product, Cleaning Samples (SWAB and Rinse Water), Process Validation Samples, R&D Samples and F&D samples. -Daily monitoring of temperature, Relative Humidity, cleaning record of QC documents. -Daily Verification, Handling, Operating and Calibration of laboratory instruments When required. -To maintain QC chemical stock. -Retain sample arrangement. -Preparation of Water Trend Data (WTD), Annual Product Quality Data (APQR) and Month Product Quality Repot (MPQR). -Working Standard preparation and reporting. -To Prepare the Raw Materials, Packing Materials and Finish Product COA When Required. -Preparation of Specification (SPC), Standard Test Procedures (STP) and Worksheet Creation of Raw Materials, Packing Materials, Bulk Sample, Finished Good Sample, Stability Sample, R&D, And F&D SAMPLES. -Protocol and Worksheet Creation, Analysis and reporting of Stability Sample. -Stability Sample Charging and withdrawals when required and analysis sample, report stability data. Evaluation of stability data and Stability Chamber. -Protocol or Worksheet Creation, Analysis and reporting of Analytical Method Validation (AMV). -Analysis and Reporting of R&D Trial Samples and F&D Samples. -Train New Chemist in Lab-Flow. -Review analytical data sheet, BMR data and BPR data. -Review Water Samples, Raw Materials, packing materials, In-process Sample, Finish Product, Stability Sample Product, Cleaning Samples (SWAB and Rinse Water), Process Validation Samples, R&D Samples and F&D samples. -Drive Quality Policy and encourage continual Improvement in Quality system at site to meet regulatory and Costumers Requirements. -Initiate the Change Control, complete the impact assessment, related Documents and Others. To ensure the closure of the change control within frequency of SOP. -Handling Incident, OOC, OOS, OOT, Change-control, Deviation, Complaint Investigation and CAPA Documents Complete and Review Them. -Exposure of Audits GMP & Customer audit etc. -Communicate with other departments for smooth work. -Communicate with external agencies for technical support.