• Responsible for analyzing and reviewing validation deliverables like Validation Plan, User Requirement specification, Functional requirement Specification, System Design Specification document. • Working on change control documentation such as Change Request Form (CRF's), Change Control Implementation Plan, Change Control Summary Report. • Quality engineering reviews and development of Work instructions, Inspection procedures, Test Method Validation & Verification, Supplier controls, IQ, OQ, PQ, Product label reviews and User requirements. • Working on systems like Trackwise, CRMS (Corporate Records Management System), Maximo EAM, Share point and Electronic Quality Management System (EQMS). • Actively involving in writing, reviewing and approving various Analytical Methods for drug substance and drug products, Method Validation Protocol, Process Validation Protocol, Cleaning Method Validation Protocol, Stability Protocols, Method Transfer Protocols, various analytical method tests Reports, new and revised SOPs, and chemistry laboratories documents. • Involving in creating Validation strategy and Validation master plan to establish a process for fulfilling the validation activities. • Responsible for Execution of test scripts and reporting using Client ALM in QA/UAT & Production Environment for Trackwise & Labware LIMS • Actively involving in Quality Management Support Activities (QMS), Control Plans, Qualifications, Process Validations, gage R&R's along with Design Verifications and Design Reviews, and implementation of new test methods. • Involving in accessing Maximo EAM tool for Equipment assets creation, Workorder Management, Preventive Maintenance Plans, Calibrations functionality. • Involving in execution of implementation plans for Preventive maintenance of equipment's and processing service requests in Maximo EAM. Required Qualification & Experience:At least a bachelors degree or higher in an engineering discipline such as industrial engineering, Mechanical Engineering, Manufacturing Engineering or a closely related field.