Summary
Overview
Work History
Education
Skills
Certification
ROLES AND RESPONSIBILITIES
Languages
Timeline
Generic
Lakshmi Manohar Reddy Mamilla

Lakshmi Manohar Reddy Mamilla

Hyderabad

Summary

Compliance leader with 19 years of experience at Cognizant Technology Solutions, focusing on SoX and GxP regulatory adherence. Demonstrated success in audit management and risk assessment, with a strong track record in team leadership and client presentations. Enhanced project delivery and compliance outcomes through effective collaboration with cross-functional teams.

Overview

20
20
years of professional experience
1
1
Certification

Work History

Lead IT SoX & GxP Compliance

Cognizant Technology Solutions
Hyderabad
12.2010 - 02.2025
  • Lakshmi Manohar has over 19 years of extensive experience primarily owning and handling responsibilities pertaining to audit, SoX, GxP compliance, and regulatory and quality assurance in the domains of pharma and life sciences, ensuring and helping clients with the implementation of SoX IT controls and compliance, such as system authentication, user access reviews, segregation of duties, change management, etc. With the help of tools like Cyber Arc, APS, etc.
  • Worked as a GxP & SoX Compliance Lead for a US Pharma client.
  • Had strong knowledge about the Quality Systems and their implementations and controls, such as Change and Release Management, Audits, Quality Reviews, Deviation, Incident Management, CAPA, etc.
  • Expertise and hands-on experience with infrastructure qualification, such as SaaS products like ServiceNow, SAP, Power BI, etc. With capabilities like strict adherence to CSV guidelines and regulatory requirements during project delivery.
  • Hands-on experience in conducting internal and external audits.
  • Support the client for the closure of internal and external audit findings or deficiencies, SoX training, and planning for the readiness of audits for the year. Helping to improve collaboration between the Audit and Application teams, and enhance outcomes with the least number of audit findings.
  • Read, understand, and assess SOC Reports Type II, along with bridge letters from sub-service organizations. Make sure to get it done on time, and every time during the assessment year.
  • Training teams internally to define SoX methodologies that are adhered to and need to be followed.
  • Overall responsibility for compliance with GxP-related standards, test report creation and review, risk management, project delivery, and maintenance of quality systems.
  • Experience with supporting internal and external audits.
  • Good knowledge of pharmaceutical software applications, such as Adverse Event Reports, PLM, SAP, and Change Life Cycle Management Systems like BMC Remedy and ServiceNow, etc.
  • Aims to deliver on time, without compromising on quality, compliance, and regulatory requirements and documentation.
  • Perform risk assessments (BPRA, FRA) and review action plans to ensure quality and compliance.
  • Lead intermediate projects, cross-functional teams, and establish links between process improvement initiatives and business strategies using effective process management skills.
  • Expertise in delivering client presentations, vendor management, and business development activities.
  • Proven expertise in managing vendors, and also experienced in authoring RFPs, project charters, SIPOC, toll gate reports, etc.
  • Worked as Validation lead for Prospective & Retrospective validation lead for Infrastructure Systems like Cloud, network devices etc.
  • Ensuring necessary Operating Procedure (SOP, GOP, and WP) trainings are completed across all GSCs (Organizational Business functions) to maintain training compliance in accordance with quality standards.
  • Understand backlog tracking, burndown metrics, and velocity for projects that are in scope.
  • Defining the testing activities to align with the Project Plan.
  • Understand prerequisites before the test activity starts, and make sure it’s in place.
  • Involved in data migration testing and software upgrade testing activities.
  • Involved in defect life cycle management and used tools like Bugzilla, JIRA, Siebel, etc.
  • Understanding the customer requirements and design of test cases.
  • Ensuring the coverage of requirements in testing activities, and taking approvals if any exceptions occur.
  • Sharing KPIs with respect to metrics and the status of overall testing with all stakeholders.
  • I had experience using the Automation Tool, Testing Anywhere, maintaining the Automation Suite, and debugging the identified issues.
  • Carry out regression testing every time changes are made to the code to fix defects.
  • Execute all the test cases, and report defects, define severity, and priority.
  • Understanding Functional Requirement Specification, Design Specification, and Testing Procedures to adopt while performing the testing.
  • Support the customer during User Acceptance Testing, and post-production or hyper support.

Test Engineer-II

Parametric Technology Corporation
Pune
01.2005 - 12.2010
  • Testing Experience
  • 5.10 Yrs.

Education

Bachelor of Engineering - Production Engineering

Swamy Ramanand Teerth Marathwada University
Nanded, Maharashtra
12.2001

Skills

  • SoX regulatory adherence
  • Audit management
  • Risk assessment
  • GxP regulatory compliance
  • Project delivery
  • Change management
  • Team leadership
  • Client presentations
  • Training development
  • Cross-functional and team collaboration
  • Critical thinking
  • Friendly, positive attitude
  • Microsoft Word
  • Microsoft Excel and PowerPoint

Certification

  • Certification Name
  • Sarbanes – Oxley Professional
  • ITIL Basics & Advanced
  • Six Sigma
  • GMP, GCP, GDP
  • GxP Audit Management
  • SoX Audit Management

ROLES AND RESPONSIBILITIES

  • Responsible for streamlining the workflow, ensuring process compliance and managing deliveries.
  • Understanding Standard Operating Procedures, System test plan, User Requirement Specification, Functional Risk Assessment, Validation summary report, Software Compliance summary report etc.
  • Conduct trainings to the team about CSV, CFR part-11, GxPs, QC etc.
  • Provide guidance to projects (which are in development phase) based on the six-sigma methodology.
  • Define validation plan / protocol, validation report including other key system deliverables to get it reviewed and approved.
  • Lead / Perform business process risk assessments, information risk assessments and Functional Risk Assessments.
  • Coordinates documentation, testing, and change management activities to ensure compliance with respect to business and regulatory needs.
  • Partnering with Quality Assurance and Business in order to align quality related processes and to achieve common agreement on standards
  • Provide facilitation techniques to identify Business requirements and RCA for potential issues/risks in the project
  • Conduct the Toll-Gate review meetings and identify the artifacts required for the project from compliance perspective for SaaS products like SAP, ServiceNow, Power BI etc.
  • Conduct meetings with Business team, Stake holders, Validation team to understand the risks involved and to plan the activities
  • Follow up with all the stake holders to complete the approval (using digital signatures) of all the artifacts involved in the project
  • Helping team members to understand the importance of completion and approval of different artifacts to enter into validation phase, completion of validation phase, deployment to production, Hyper care and Go-Live etc.
  • Creation of different artifacts Computer System Validation Plan, Computer System Validation Report, Revalidation Plan & Report, GxPs Trainings, Traceability Matrix, Test Plan, Status Reports, Test Plan report etc.
  • Doing the peer review of different artifacts, before it get delivered to customer for approval
  • Update the Status Report & Risks involved to the business team and other stake holders involved
  • Understanding the Validation SOP’s from client perspective and make sure the Validation Process is aligned with delivery from offshore
  • Lead validation team and manage the testing and validation delivery from offshore
  • Helping team to understand the roles and responsibilities during computer system validation phase.
  • Creating of different artifacts FRA, Traceability Matrix, Status Reports, Test Plan report etc.
  • Update the Status Report to the business team and other stake holders involved
  • Creation of different artifacts Traceability Matrix, Test Plan, Status Reports, Test Plan report etc.
  • Interaction with Client to update the status and risks involved in the project from validation perspective (During Project development & Operations)
  • Support during External and Internal Audit of projects, helping project team to close the Audit observations in time
  • Support during the transition process & ensure it goes smooth when project moves from Project phase to Operations phase.
  • Review the artifacts like Handover Checklist, Operations Handbook etc.
  • Monitoring the periodic review of applications, like User Access, Audit Trail, Periodic Revalidation, Change Reviews, Backup & Restore etc.
  • Conducted Audits and Prepare Audit review reports for other client accounts
  • Part of defect management system and used HP QC to review and monitor
  • Been part of creation of RFPs in the process of bidding new projects (From Regulatory and Compliance perspective) from Cognizant.
  • Creation of Project Plan with efforts required for completion of project
  • Manage project team around 10+
  • Lean Six Sigma about the process of onboarding new associates
  • Business Analyst, Facilitation Techniques, requirements gathering with respect to Functional, Business, Security, Report requirements etc.
  • Good in applying Conflict resolution techniques within the team & cross functional teams
  • Having strong CSV Validation expertise in the technology domain: Block Chain Technology, Artificial Intelligence & Cloud Infrastructure

Languages

English, Hindi, Marathi, Telugu

Timeline

Lead IT SoX & GxP Compliance

Cognizant Technology Solutions
12.2010 - 02.2025

Test Engineer-II

Parametric Technology Corporation
01.2005 - 12.2010

Bachelor of Engineering - Production Engineering

Swamy Ramanand Teerth Marathwada University

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Lakshmi Manohar Reddy Mamilla