YAMAJI BALAJI NAJAN

Developed skills in fast-paced production environment, focusing on process optimization and team coordination. Seeking to transition into new field where skills in project management and quality assurance can be impactful. Aiming to leverage problem-solving abilities and operational insights to drive success in dynamic workplace.

• Handling Knowledge to maintain the Equipment’s which contains different unit operations in Plant through PAS-X Software (MES), HMI (DCS), TCU (Temperature Control Unit ) and Manual Operations.
• Perform Operational Qualification, Performance Qualification, Passivation.
• Complete all documentation according with Good Manufacturing Practices and GoodDistribution Practices.
• Excellent in understanding and application of Global Regulatory (cGMp/ICH/FDA) guidelines.
• Initiation of the change controls & Deviations and closure documents submit to QA, CAPA implementation, SOP preparation, Handling Document management system software, Audit compliance.
• Provide guidance and coordination for all aspects related to the initiation, tracking and management of all Manufacturing Investigation Reports and Laboratory Investigation Reports, Corrective Action and Preventative Action (CAPA), evaluation of CAPA effectiveness through Effectiveness Check.
• Review And Preparation of Process Validation and Cleaning Record Protocol.
• Manage investigations and apply relevant and necessary actions/systems to ensure appropriate levels of compliance.
• Take part in deviations, OOS, complaints investigation with other department and follow up CAPA.
• Knowledge of Troubleshooting and Problem-solving skills,e.g., formal root cause analysis such as Ishikawa Diagrams, FMEA etc.
• Knowledge of Lean, Kaizen, and Continuous Improvement initiatives.
• Monitor the plant status and liaise with colleagues of other departments to ensure there is no interruption to manufacturing process and Collaborate with cross-functional teams to ensure alignment of improvement initiatives with business goals.
• Support to routine shopfloor's supervising activities like weekly shift arrangement for operators, special production materials requirement communication, equipment status (breakdowns, urgent maintenance, pre-maintenance etc) monitoring,SOP implementation compliance in shopfloor, shopfloor's supervising
• Evaluate data, trends and report results to management.
• Strong background in continuous improvement methodology (i.e., Lean Six Sigma).
• Perform material receiving, staging, transfer, dispensing, sampling, and charging operation.
• Execution of Trail & validation batches as per the batch planning & schedule and Process improvement and Support process validation.
• Responsible for routine and preventive maintenance work, ensure all the equipment and facilities work safely, efficiently and reliably.
• Proactively monitor, identify, develop and implement improvements in processes and equipment.
• Coordinate with internal and external auditors to conduct audit programs and follow through when needed.
• Handling of cleaning swab activities.
• Handling of clean room Fumigation activities.

• Stainless Steel & Glass Lined Reactor
• Vacuum Tray Dryer
• Centrifuge
• Air Jet Mill
• Rota Cone Vacuum Dryer
• Multi MILL
• Agitator Nutch Filter And Dryer
• Nutch and Sparkler Filter
• Sifter

• Project and Paper Presented entitled "Preparation of Paper by using Non-wood fibre" in India International Science Festival (IISF-2018) organized in Lucknow on November2018.
• Participated in Start-up India, Nagpur-2018.
• Certificate of Excellence in the “Lean Six Sigma AI Yellow Belt”.
• Certificate of Appreciation in “Quality Management System in Pharmaceutical Industry”.

• Internship in FIL( Finolex Industries Limited). Duration:07/01/2019 to12/01/2019
• Studied industrial manufacturing process to produce PVC( Polyvinyl Chloride)
• Familiarised with equipments used in the process such as furnace, Boiler, Distillation tower, ETP (Effluent treatment plant).
• Industrial Training in Excel Industries Ltd, Lote.
• Industrial Visit at Vinati Oragincs Ltd, Lote.
• Attended a one day workshop on "Intellectual Property Rights".

• Ability to work independently and also in a team.
• Focused and committed towards the given assignment and responsibilities
• Well organized, attention to detail, and easily adapt to change.
• Effective team member by means of strong interpersonal skills
• Confident, energetic and positive attitude
• Intelligent, motivated, resourceful, reliable.