Ravithej Dantala

Experience

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  KL University

  Jun 2011 - Dec 2012

  Operations & Auditing Manager [Entreprenuership Developement Cell]

  • Managing funds released for Entrepreneurship Development Cell.• Develop & implement internal auditing policies, procedures, & program.• Create a detailed schedule based on strict deadlines.

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  MAC MACHINE TOOLS AND AUTOMATION

  Dec 2012 - Jan 2015

  Engineer (Service & Projects)I. Projects a. Design and develop software applications based on given requirements and specifications.b. Technical writing including Validation Test Plans, Analysis/Development/Validation Plan and Reports. c. Review engineering deliverable & initiate appropriate corrective actions.d. Performing Integration Testing, System Testing and assisting User Acceptance Testing at site.e. Working closely with clients to develop, coordinate and execute Validation documents and strategies. II. Servicea. Annual Maintenance of Executed Projects.b. Troubleshoot issues with existing company installed systems.c. Hypercare support/post-deployment support for the systems. Show less

  • Engineer

    Jun 2013 - Jan 2015

  • Intern

    Dec 2012 - May 2013
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  Mylan

  Feb 2015 - Oct 2018

  Subject Matter Expert for Industrial Control Systems & IT Applications.Responsible for designing, developing, installing, managing & maintaining equipment which is used to monitor & control engineering systems, machinery & processes. a. Industrial Automation I. Programmable Logical Controllers (PLC) (Siemens, Allen Bradley, Mitsubishi, Delta) II. Human Machine Inter-phase (HMI) (Siemens, Allen Bradley, Mitsubishi, Delta) III. Supervisory Control & Data Acquisition (SCADA) (Siemens, Allen Bradley) IV. Drives (Variable Frequency & Servo) (Siemens, Allen Bradley)V. Networks ( Filed Bus, Profi Bus, Profi Net, Ether Net, Control Net, Device Net)b. Knowledge on StandardsI. ISA-88 Batch ControlII. ISA-95 Enterprise-Control System Integration III. GAMP5 Compliant Gxp Computerized Systems c. Quality Management System I. Correct Action & Preventive Action and Change Control Management using Track-wise. II. Ensuring compliance with quality standards (ISO 9001:2015).d. IT Applications ValidationI. Determining validation requirements for computerized & manufacturing systems.II. Carry out Validations (e.g. FDA 21 CFR Part 11, Part 820, etc.).III. Preparation & completion of computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, Summary report).IV. Monitoring Business continuity management, Backup & Restore. Show less Responsible for Process Engineering, Facilities Management: I. Determining validation requirements for computerised & manufacturing systems.II. Carry out Validations (e.g. FDA 21 CFR Part 11, Part 820, etc.).III. Preparation & completion of computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, Summary report).IV. Monitoring Business continuity management, Backup & Restore.V. Designing, implementing, and optimizing pharmaceutical manufacturing processes to ensure the highest level of quality and efficiency.VI Collaborating with cross-functional teams to develop and scale-up production processes for new pharmaceutical products.VII Conducting thorough analyses to identify areas for process improvement and leading initiatives to enhance manufacturing efficiency and reduce costs.VIII Ensuring compliance with regulatory standards and guidelines, including cGMP and FDA requirements, and participating in regulatory inspections and audits.IX Developing and maintaining detailed documentation related to production processes, including batch records, standard operating procedures (SOPs), and change controls.X Troubleshooting and resolving technical issues that arise during pharmaceutical manufacturing, working to prevent deviations and non-conformances. Show less

  • Senior Executive

    May 2017 - Oct 2018

  • Senior Associate

    Feb 2015 - Apr 2017
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  EY

  Oct 2018 - Apr 2019

  IT Consultant

  Responsible for participating in the Validation Life Cycle of regulated IT projects or platforms related to Trackwise.• Analyzing the Requirements from the client.• Preparing Test Scenarios & Test Data’s.• Preparing Test Cases for module, integration & system testing.• Analyzing the Test Cases prepared by other team members• Executing the Test Cases, Defect Tracking & working closely with cross-functional project teams.• Giving mandatory information of a defect to developers in order to fix it.• Ensure 21 CFR Part 11 compliance for computerized system.• Responsible for reducing Gaps identified in various GAP/Risk Assessments existing & new computerized system and provide remedial action plan for compliance.• Manage the specified business / systems requirements, working closely with the designated Project Manager to facilitate progress of the project. Show less

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  Philips

  Apr 2019 - Jul 2020

  Test Validation Engineer

  Payroll: Ciber, Bangalore.Responsible for participating in the Validation Life Cycle of regulated IT projects or platforms by planning validation deliverables.• IT quality systems framework design & implementation.• Development of integrated GxP & IT compliance.• Ensure 21 CFR Part 11 compliance for computerized system.• Responsible for reducing Gaps identified in various GAP/Risk Assessments existing & new computerized system and provide remedial action plan for compliance.• Carrying out Audit of IT systems to ensure regulatory compliance.• Manage the specified business / systems requirements, working closely with the designated Project Manager to facilitate progress of the project and provide technical leadership, as needed.• Perform a wide variety of activities pertaining to compliance with applicable regulatory requirements, quality management system (QMS) maintenance, improvement and harmonization, and quality control and assurance.• Verification of execution of processes and their deliverable's in product creation and report the findings to upper management.• Review and Approval of designated project documentation in product creation projects.• Ensure that appropriate SW Quality plans are made that include all stages of the software life cycle and supports SW Quality Plan design.• Provides effective oversight of the execution of the SW Quality Plan and any Risk Management activities, and of all design related activities during the software life cycle.• Lead quality related problem solving for software. Show less

• 

  KL University

  Jun 2019 - May 2020

  External Member of B.O.S (Board Of Studies)

  • To recommend courses of studies, teaching & examinations scheme in respective subject.• To decide scheme of evaluation for the Semester End Examination,• To design curriculum & advise on all matters relating to respective subjects referred by the faculty & make recommendations to the academic council of KLEF for 2019-20 admitted Btech-EEE.• To recommend books & reading materials for subjects concerned.

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  Novo Nordisk

  Jul 2020 - now

  - Act as the primary liaison between stakeholders, including customers, development teams, and other key business units, to define and prioritize product features.- Develop and maintain a clear and comprehensive product backlog, ensuring that it accurately reflects - customer and business priorities.- Collaborate closely with cross-functional teams to define product requirements, user stories, and acceptance criteria, providing clear guidance to development teams.- Drive the product development process, participating in sprint planning, review sessions, and retrospectives, and ensuring that deliverables meet quality standards and customer expectations.- Continuously gather and analyse feedback from customers and stakeholders to inform product enhancements and new feature development.- Champion the product vision, ensuring alignment with organizational goals and customer needs, and providing transparent and consistent communication across all stakeholders. Show less • Release Management in Data Management & Analytics area• Work along with team in ensuring validated state of product by acting as liaison between Quality Assurance and the product team to assure that the Quality & Compliance requirements as per company QMS procedures and regulatory guidelines are met.• Participate in system releases while performing Validation responsible role with technical understanding reviewing Quality Risk Assessment, a coordination / Validation and Defect Management, etc, meeting the Quality & Compliance requirements as per company QMS procedures and regulatory guidelines.• Support product owner on the team as and when required. Demonstrate pro-activeness and ownership. Should take complete ownership for the tasks and drive to completion. Understand business complexities and different perspectives of the same.• Handling Change Request to comply with the Change management work instructions. Support system releases while performing as Release Manager & validation responsible role, as applicable. You will be monitoring the effectiveness of incident and problem management process and make recommendations for improvement.• Manage global stakeholders which include internal parties (Product managers/Product Owner area, System Owners, Department Manager, etc.) and external parties (customer, consultants, vendors, etc.) for high level collaboration.• Handle turning around deliverables with time-sensitive deadlines and quick turnarounds. • Work in multiple time zones Show less Responsible for the following: Perform various assessments including IT Risk Assessment, Requirements Risk assessment, functional, data integrity and supplier assessments. Define test strategy, manage test execution, review and reporting in line with STLC including handling validation deviations. Perform CAPA and RCA end to end change management including handling deviations both during the project and operation phase.Participate in audits and inspections including finding solutions to compliance gaps identified in audit/ inspections. Provide compliance consulting for the IT projects and deliver compliance deliverables with respect to CSV/ CSA.Be responsible as a Service Manager for multiple projects to provide end to end service delivery management of the assigned/owned services. Show less

  • Product Owner

    Jan 2024 - now

  • Advanced Business Analyst II

    Apr 2023 - Dec 2023

  • Advanced Business Analyst I

    Jul 2020 - Mar 2023