Anirban Mahato

• Currently working as Operations Quality Manager at Infosys Ltd .

• Having experience in Software Validation, good documentation knowledge on Computer System Validation.

• Familiar on FDA regulatory process like 21 CFR Part 11, EU Annex 11 and GxP assessment in regards to the Validation process.

• Deviation handling and CAPA implementation.

• Experience in preparation of validation protocols.

• Having good documentation knowledge in preparation/reviewing of URS, VP, FRA, FS, DD, IQ, OQ, PQ, TM ,Retirement Reports & Retirement Plan VSR, PRR Documents ( Production Review Report ), Emergency Changes .

• Through knowledge in Requirement /Use cases Analysis, Test Planning, Test design, Test execution, Risk identification and management and project closure activities.

• Having good knowledge on Periodic Reviews of Pharma Applications and its Control Activities .

• Experience in developing/Reviewing Test Plans, Test Strategies and Test Cases.

• Experienced in understanding and reviewing software requirements, designing test cases.

• Experience in Functional testing, System testing and End To End Testing.

• Review and approve all life cycle document and test result in document management tool.

• Helping Leads in monitoring compliance status of various IT processes (e.g. change management, Incident management, problem management etc.)

• Review and finalize IT process gap report on monthly basis for identified deviations & track all CAPA action for closure.

• Maintaining deviation reports for the GDP reviews done and passing feedbacks to the Project and Change managers on regular intervals .

• Implement corrective and preventive actions effectively for the identified deviations.

• Excellent communication and coordination skills with onsite and offshore teams.

• Ability to learn new technologies in short span and implement independently.

• Good team player and can work independently.

• Also I am playing a role of Quality Enabler in “ Asset Management “ area , Any queries related to Asset Management for an application is dealt by me .

• Have good knowledge in Software procurement and Software Licensing of Applications .

• Worked as Senior Process Executive in Pharma Domain,Where I use to provide support & assistance to our Application users when they faced any technical glitch during access .

• Use to raise access for the newly On-boarded team members by validating there mandatory trainings in Complaint or no .( UAM- User Access Management )

• Conduct class room trainings for the newly On-boarded team members for the process related issues .

• Generated monthly metric reports, interpreted results and developed processes and solutions.
• Determined change management needs and defined behaviors for effective program management.

• Demonstrated respect, friendliness and willingness to help wherever needed.
• Passionate about learning and committed to continual improvement.
• Paid attention to detail while completing assignments.
• Developed strong communication and organizational skills through working on group projects.
• Provided on call primary Support and Virtual Support to the Medical equipment/Device users and use to identify the issue and categorize if High /Medium / Low Risk , Based upon that assigning specialist to the task .

• Helped large volume of customers every day with positive attitude and focus on customer satisfaction.
• Responded to customer calls and emails to answer questions about products and services.
• Developed and actualized customer service initiatives to decrease wait times.
• Maintained customer satisfaction with forward-thinking strategies focused on addressing customer needs and resolving concerns.