Alok Khuntia

Career Objective:

With ** years of experience across IT Validation, 21 CFR Part 11, Operations Maintenance, Quality Assurance, Client Relationship Management, SDLC and Data Analysis. Expertise in Validation(IT Systems)/GxP regulations/21 CFR Part 11.Knowledge of Computer Systems Validation, System Development Life Cycle, and GAMP4 guidelines .

Ensuring & conducting the training of the users on the new and existing software solutions, IT SOPs. To arrange / conduct the IT team training on new IT SOPs.

Well versed with Quality Assurance processes, Test strategies and Test Methodologies

Prioritize multi-tasks effectively; taking into account factors such as project scope, deadlines and urgency of need to ensure business results are met.

Lead testing process improvement activities, to identify and resolve quality related issues across organizational boundaries. Worked for the major customers like:

CVS Pharmacy (USA),

AT&T (USA) .

Pfizer AG.

Novartis Pharmaceuticals Corporation,NJ,USA

Bluefish Pharmaceuticals AB,Sweden.

Bristol-Myers Squibb,NY,USA

Amneal Pharmaceuticals

Technical Skills:

●Sound interpretation & implementation of ICH, WHO and FDA requirements for marketed products & conducting clinical trials and biomedical research.

●GXP-Quality Management Systems

●Policies, SOP, WI, Templates & Manual development

●Approaches & Strategies (risk based, metrics based, etc) for 21 CFR Part 11 & EU Annex 11 compliant Computer system validation

●Development & technical documentation of CSV Package in compliance with Good Documentation Practice.

●Validation implementation phases & respective strategy/approaches (risk-based/ metrics-based) in regulated environment.

●Methodologies for Software Development Life cycle (Agile & waterfall) & Software Test Life Cycle in regulated environment.

●Clinical Data Management Systems & Electronic data capture tools, including Data Validation and Data Visualization techniques.

●Audits, Gap Analysis & CAPA

●HIPAA, GDPR compliance for IT systems and processes for life sciences.

●Clinical Safety Reporting systems

●Regulatory Gap Assessments & Remediation

●Risk Management & compliance, Risk/benefit analysis and comparative risk assessments, incl. RiskMap & REMS for GxP critical systems & processes.

●Electronic Document /Record Management Systems-Good Documentation Practices & Data Integrity Practices

●EU Annex 11

Additional Skills:

Quick Learner, Good Communication, Analytical Skills, Team Management, Team Player Skills.

Professional Experience

Amneal Pharmaceuticals Pvt. Ltd.

Senior Manager CSV-IT

August 2021 - Present

Currently I am involved in validating LIMS application for US based plants .

Entrues Business Services India Pvt. Ltd.

Senior Validation Manager/ Project Manager

June 2015 – July 2021 (6 years)

Manage and maintain compliance for On-Prem and Cloud infrastructure for my current client.

Conduct internal audits to identify gaps and work to fill the gaps.

Mange the scope of the project deliverables and defines a plan and reporting and governance structure to manage it.

Manage the execution against the plan to achieve the desired result, resources, budget, scope, and maintaining regular reporting and risks and issues management.

Lead and perform risk-based validation of GxP systems, develops validation documents using defined CSV process, and communicates project progress throughout the system lifecycle.

Publishing the project success results and manages communication with stakeholders on progress of project as well as issues.

Manage the team delivering into the project both in terms of performance and results to ensure success.

Collaborate with vendor(s), quality, and technical individuals throughout project in generation of project / qualification required deliverables.

Communicate status, solutions and concerns. Disseminate information in a timely manner within the team.

Drive and coordinate system related Change Requests and Deviations / Non-Conformance, in accordance to governing GxP procedures.

Understand the scope of M&A objectives.

Analyzed business requirements; interacted with customers; defined development procedures; implemented project plans; defined best practices for project support and documentation.

Contributed to solution designing to execution as a project managed consultant/Program Manager.

Evaluation and management of changes effectively as part of the Project lifecycle.

I Work directly with customers during the implementation of a new application installations to validate the system and again when upgrading application versions to maintain this validated state.

Validate system implementations, system upgrades and creates system documentation in accordance with computerized system validation plan and protocols. Deliverables will include Validation Plan, User and Functional Requirements, Requirements Traceability Matrix (RTM), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Validation Summary report.

Facilitate verification and validation activities such as User Acceptance Testing (UAT), test execution, documentation review, and approval. Extensive experience with Infrastructure Qualification is required.

Responsible and accountable for the development and delivery of a complete validation package: User Requirements Specification (URS), Validation Plan (VP), Installation/Operational/Performance Performance Qualification(PQ), Installation Qualification (IQ), Functional Requirements Specification (FRS), Operational Qualification(OQ), Performance Qualification (PQ), Traceability Matrix (TM), Validation Summary Report (VSR), Configurations Specification (CS), Administration and User SOPs, Work Instruction (WIs).

Oversee and take part in the formal test execution of IQ, OQ and PQ to ensure the testing was performed appropriately and the test results are compiled in a timely manner.

Review and/or approve validation documents and related deliverables, such as Configurations Specification (CS), executed test scripts, and system-specific Admin and User SOPs.

Pariksha Labs Private Limited

Manager-Testing

July 2013 - May 2015 (1 year 10 months)

Was working in a Mobile App Project :- RePill, the first Swiss app with an integrated medicine database, was developed for Absolute Development AG with the support of Pfizer AG.This app helps patients to manage their medicine prescriptions and supply.

●A reporting module lets the physician have information on how the consumer is taking his/her medicines.

●And a Drug Utilization Review system helps the user to identifying potential adverse drug events in health care that may lead to hospitalization, So this app helps the user to see the DUR before consumption.

●Lead the validation activities for a global serialization & project rollout Developing and managing GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance testing, traceability matrix, system, Validation Reports, SOPs, Change Control Documentation, and Risk assessment reports. Conducting System Compliance Risk Assessment

●Managing and coordinating all aspects of the computer systems validation activities as they pertain to SDLC, including project planning, developing validation strategies, document development and document reviews Overseeing system change requests and associated documentation Managing documentation logs and document storage Maintaining system SOPs

●Utilization of a risk based approach to determine the validation requirements Configuration specifications generation detailing the specific configuration of the systems / interfaces

●Project change control implementation in accordance with requirements, design and system changes

●Identify risks and clearly communicate them to project stakeholders

Tech Mahindra (formerly Mahindra Satyam)

Technical Associate

April 2011 - August 2011 (5 months)

Determine automation needs and performance testing strategies and Support Software Quality automation for functional, regression, system and performance testing.

Maintain the necessary test frameworks, templates, tools and scripts to support the end-to-end test strategy and test plans, and ensure uniform adoption across the teams.

●Ensure that the teams follows and adheres to all processes and disciplines, Communicate and create clarity with teams on project objectives and expectations and break down assignments into tasks.

●Ensure test iterations including Issue Testing, System Build Testing, Regression Testing and Integration Testing.

●Ensure that the technical testing of the product is done with required rigor in prescribed timelines and drive team excellence.

●Manage team performance & progress by conducting Review and Acceptance of Testing quality and Output.

●Ensure the accuracy and consistency of data results through thorough documentation processes.

●Coordinate with the development team to perform root-cause analysis and preliminary problem diagnosis.

●Participate in designing the Testing Process.

Tata Consultancy Services

Test Analyst

October 2006 - August 2010 (3 years 11 months)

Worked for major clients like Eli Lilly (USA),CVS Pharmacy (USA).

Supports Test Lead in the test pack preparation and test execution for UAT, QA and Performance Testing against the plan and its targets Test Preparation:

●Contributes to defining the test packs (test scenarios, test cases and test scripts) and facilitate the review and sign off with business users. Responsible for the creation and / or application of test data. Participate in Requirements & FSD walk-throughs

●Test Execution / Defect Management

●Responsible for executing the test packs created in the preparation stage.

●Supports the test lead to ensure defects raised are classified according to priority by the business users during UAT and are appropriately managed and communicated on time to the development team for fix.

●Escalates key issues and risks when appropriate to Testing Lead

●Ensures testing status progress and next steps are regularly communicated to Test Lead.

●Assists in obtaining Sign off from the Stakeholders at the end of the Testing period.

Seashore Group of Companies

IT Process Analyst

June 2005 - September 2006 (1 year 4 months)

●Identify and manage resources, risks, and procurement related to the project to avoid unforeseen delays and to ensure that contingency plans are in place.

●Involved in assessing scalability in terms of response times, server performance, database performance and points of failure under different load conditions.

●Involved in Benchmarking the performance of the application under load conditions to analyze impact to performance from various server configurations.

●Understand the business requirements and implement technical, cost effective solution.

●Collaborate with the business to identify and automate business processes and workflows.

●Single point contact for all branches IT needs.

●Controller of application change Environment management.

●Work with in budgets, able to optimize spending.

●Document key project learning at the end of each project to ensure that the learning from each project is not lost and to avoid re-invention of the wheel.

Education:

CDAC Noida (Guru Gobind Singh Indraprastha University)

Master of Business Administration (M.B.A.), Software Enterprise Management · (2011 - 2013)

Visvesvaraya National Institute of Technology

Bachelor in Engineering Degree (2001 - 2005)

Contact this candidate