Harish Kumar A Email & Phone Number

● Regular in process checks, on line BMR, BPR Entries, Reconciliation & maintain all log Books.● Maintenance of Shop floor discipline, Solve Routine Problems and handle grievances proactively through counseling.● Liaison with other departments gains information, resources and takes help for day to day activities.● To monitor environment controls and coordinate with preventive maintenance of all equipment’s to minimize downtime and to ensure product quality.● To authorize the batch records, additional material request forms, excess material return forms, deviation approval forms, reprocess approval forms etc. in the absence of PM/DPM.● To ensure all safety features of equipments are functioning properly.● Preparation and review of SOP’s.● Proper handling of documentation, incidence and deviations.● To co-ordinate with production and QA to close change control and deviation related to validation, batches. ● Responsible to review of BMR, Validation protocol, Validation report and other system related documents.● To co-ordinate with QA for qualification activities like IQ, OQ & PQ.● Execution of exhibit/validation batches by coordination of cross functional departments.● Responsible for involvement of process optimization trials and data generation.● Responsible for batch yield improvement.● Creating & submission of monthly reports.● Preparation & Evaluation of computerized system for GxP Assessment, GAMP Categorization and applicability to 21CFR.● Develop the user requirements specification (URS) to document the intended use of the computerized system which includes Functions, Security, Data, Regulatory, Performance, Interfaces, Migration, Data backup/restore.● Develop a validation plan that is maintained throughout the lifecycle of the computerized system. ● To verify how the computerized system shall meet the requirements defined in the URS according to FRS.● Review the design specification, technical specification and functional risk assessment. ● Preparation and Execution of Installation qualification, which includes writing script and its documentation for both quality & production server.● Preparation and Execution of OQ and PQ jointly with users, writing script which includes challenge/Negative test, Process test and its documentation.● Periodic review of software applications.● System retirement and its documentation.● Independently perform investigations, Address out of specifications (OOS), Resolve deviations and implement CAPA. ● Demonstrate solid knowledge of cGMP & GDP practices.