Visits / Quality Audits of current and new CMOs, Handling of Market Complaints, GxP Trainings, Quality Management System, Regulatory Compliance

Handling overall responsibility of Document management & Archival system.Preparation & review of master documents like SOP, Specifications, Test methods, SOP training matrix, Stability Protocols, Quality Manual, COAs etc.Handling Quality Management System for Market complaints in Trackwise module.Complete responsibility of SOP Training of all employees in compliance of SOP training matrix via LMS software.Artwork Management: Development & Revision of artworks for New product launch, CCDS updates, Address change, Price revision & other artworks changes as per RA variations in coordination with Artwork agency, Global PACO & Engineer, internal departments. Coordination with Printer for feasibility checks. GTP & Shade cards approval. Independent responsibility for Analytical testing of Import consignments (FP & API) in coordination with Government testing laboratories for DCGI & ADC release. Handling & management of standards & Impurity standards. Provide input details for import permission of standards & impurity standards in coordination with Regulatory department.Stability study of Local products. Maintain Temperature & humidity Records for stability chambers.Checking of pharmacopeia updates for desired formulations.Calibrations of equipments like HPLC, UV-Spectrophotometer, Dissolution, pH meter, Balance, Karl-Fischer Titrator etc.Biological Assay of two confidential molecules (API and FP).

Analytical & biological testing of API & Finished products & stability samples.Chemical & Microbiological testing of water systems.Preparation of Specifications, Test methods, COA, analysis formats for API, Excipients & formulations. specifications.Preparation & Management of SOPBasic Microbiological testing like Sterility, Total CFU, GPT for Media.Maintain laboratory records & logbooks in accordance to cGMP requirements.Analysis of printed packing materialsHandling of Shop floor activities (IPQC). Checking of Batch Manufacturing Record & Batch Packing Record.

Chemical testing of Water.Perform sampling & analysis of packing materials like vials, ampoules, rubber closures, seals, labels, cartons, leaflets, shippers, etc.Development of artwork for cartons and labels for formulations.Preparation of analytical solutions, mobile phase.Dispensing of raw materials & excipients.In-process check for Washing, sterilization, filling, optical checking, labeling, packing.Analysis of finished products like Dry Powder Injectable, Liquid Injectable, etc.Document Management & implementation.Calibrations of different machines & instruments.