• Responsible for the Implementation of TPM initiatives across the organization, cross functional working across different functions• Good knowledge in TPM pillar and methodologies• Leand and execute the TPM and 5S culture and program for the plant as well as guide the company standards within the plant • Coordinate with the operations, maintenance and engineering teams to develop and improve the autonomous, preventive, reliability maintenance• Providing coaching, monitoring and training on the TPM methodologies.• Executing a TPM learning and training plan for the plant.• Good knowledge on Root cause Analysis of Why-Why Analysis.• Good knowledge on FMEA, Pareto chart, affinity diagram, Fishbone/Ishikawa, C & E Matrix• Has gained expertise all the phases of software and computer system validations according to 21 CFR part 11 and GxP FDA regulations.• Excellent knowledge and experience in good documentation practices.• Good experience in authoring and reviewing of validation plan, Risk Assessment, Specification (URS, PRS, DQ), Validation summary report, periodic validation report.• Involved in GAMP analysis, root cause analysis, corrective and preventive actions (CAPA) reporting, handling and closing of identified defects and findings.• Prepare validation plan, risk management plan and perform functional risk assessment as per applicable compliance with GAMP 5 quality risk management. • Responsible for Instrumentation breakdowns and solving them within the timelines and reducing the equipment down time. • Having in exposure of Good Engineering Practices. GMP guideline of USFDA, EU & WHO-GMP in reference to engineering functions.