Manager Project

HALEEL ANWAR BASHA Cognizant Technology Solutions

Sr. Consultant – Validation Service Cell: 480-***-****

E-mail: ******.*****@*****.***

Summary

Having over 13 years of IT industry experience, focused on validation & compliance services, specialized in Pharmaceutical FDA regulated industry. Experienced with different validation roles (Validation SME, Compliance Lead, Validation Lead, Validation Analyst, Validation Engineer, Validation Program Manager, QA Lead, QA Manager, Compliance Auditor, Deliverable Manager and Compliance Lead)played with various US global pharmaceutical customers and involved in all the phases of Life Sciences SDLC.

Validation Consultant / Manager – Manages a department of Validation team members for validation programs. Coordinates and provides overall direction and expertise for administration of validation policies in compliance with Quality System Regulations to different internal organizational groups, customers and vendors. Writes and conducts performance reviews, provides ongoing performance feedback. Service provided for regulated environments (IQ,OQ &PQ) and non-regulated environments. Worked with RBG, PMO, Shared Services, ITO, Business, Testing, Development and Compliance teams to ensure project team complies with the methodology, SOP and uses the correct tools. Especially manage and supervise to ensure the GDP across all the projects. CSV document draft, review & approval. Good exposure in Validation Testing, Security, Privacy, Confidential, 21CFRPart 11, Part 210, Part 211, SoX, HIPPA, Change Controls, Release Controls and decommissioning areas.

QA / Testing - Services – Had good experience in Testing Services, hands on experience in all types of testing like Smoke, System, Integration, Functional, Database, Data Migration, browser compatibility, multilingual, batch process, web service, usability, alpha, beta, Sanity, Automation, Performance and User Acceptance Testing. Provided guidance and support to draft, review and execute test cases to business, vendors & clients. As a delivery head, review and approve all the testing deliverables. Generate and present the Quality &Testing Metrics to leadership team to support decision making.

Computer System Validation – Has good experience in QCSV, Performed CSV for multiple systems including Product testing, People Soft, Advert Event, LIMS, CCMS, Pharmacovigilance Management Systems, Commercial Product Sale, Product sales, Pharma Product sales, Personal Insurance, Auto Insurance, Insurance Agent Management System, Data Migration, Data warehousing, ETL-Informatica, Cognos, Sales force, Labeling batch process management system, Service now, Exceed, CCMS–Component Content Management Systems, Agent Management System, Seibel CRM, Banking CRM, Informatica-Cognos Reports, SharePoint, Security systems, Lotus Notes, Crystal Reports, Mainframe JCL, EDW Reports, batch process validation and Investments applications

Domain Knowledge – Experienced with various domains and served to multiple customers includes Pharmaceutical/HealthCare (Cognizant – BioMérieux, Sanofi, Johnson & Johnson, Animas, Abbvie, Abbot Laboratories)

Academic Qualification – Bachelor of Science in Computer Science & Master of Science in Computer Technology

Skills –

FUNCTIONAL

TECHNICAL

oProject & Quality Management

oDelivery Management

oResource Management

oTesting, Validation & Compliance SME

oPharma, Insurance & Banking Domain

oProcess management

oSetup Center of Excellence

oCSV Application Project Management

oTest Management Tools – HPALM, Silk Central, JIRA

oDB Tools - TOAD, Query Analyzer

oDatabase – Dbase, FoxPro, SQL, Oracle

oAutomation Tools – QTP(Basics), Load Runner, Perfecto (mobility testing)

oDocument Management Tools - EDMS, Documentum, SharePoint.

oProcess Management Tool – Service Now & EDMS

Coordinate process validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others

Coordinate and conduct Risk Assessment meeting & process to identify the system decisions.

Manage deliverables – Project Plan, Validation Plan, Risk Assessment, Trace Matrix, summary report and Metrics reports.

Work closely with business and support to train / draft requirements and demands.

Perform GAP analysis and create CAPAs for gaps & audit findings.

Provide project management/oversight for process validation activities related to Pharmaceutical clients.

Work with architect to perform due diligence and support to identify right tools

Maintain current knowledge of industry standards and regulatory requirements for products developed and manufactured by Clients, validation techniques/approaches and systems utilized at Client place.

Lead and represent Validation in multi-departmental meetings & project teams owned by QAPV.

Assist to design, review and pre-approve all the CSV deliverables - validation plans, protocols, trace matrix, validation summary reports.

Work closely with Validation Manager and QA Compliance to ensure appropriate validation of cGMP computer systems.

Conduct Triage, Test Status and leadership meetings in regular interval.

Assistant client business team to perform UAT testing, incident management and release plan.

Closely work with the business analyst to ensure conformance to User & Functional specifications.

Involved in Test Strategy and Test plan preparation.

Design, Review Metrics with test results with stakeholders to identify root cause & GAP analysis.

Design Test Summary Reports at the end of testing. Doc revisions to ETS Testing Proc.

Generating Weekly Status report and Monthly Status report.

Coordinate and provide input for Automation Testing Team and Performance Testing Team based on functionality testing’s coverage, result and latest change request.

Discussing the project risks and sharing the mitigation plan with the client.

EMPLOYMENT HISTORY:

Company Name

Designation

From Date

To Date

Duration

Cognizant Technology Solutions

QA Manager

2007 Mar

Till Date

9.1

THOMSON Reuters

SQA

2005 Dec

2007 Feb

1.3

HCL Technologies

Test Consultant

2005 Jul

2005 Dec

.6

Maverick Systems

Sr. Test Engineer

2004 Aug

2005 Jun

.11

Tiara Techtronic’s

Test Engineer

2002 Feb

2004 Aug

2.6

PROJECT PROFILE:

PROJECT Details: CCMS – Component Content Management Systems, LIMS, NEPTUNE, SAPHANNA, and ANTIVIRUS – Aug 2015 to Present, Senior Validation Consultant in bioMérieux (Through Cognizant Technology Solutions)

RESPONSIBILITIES:

-Setup TCoE – Verification & Validation Center of Excellence.

-Understand the business requirement, review and approve test cases and project deliverables.

-Work with PMO for estimation, planning, execution, deliverable management & escalation management.

-Review and approve CSV deliverables to ensure the adequacy and completeness.

-Coordination program with clients, onshore & offshore QA Teams.

-Provide reports to Client & Cognizant leadership team.

-Author and execute process validation protocols and necessary documentation to complete validations.

-Knowledge of statistical analysis in order to detect and control variability.

-Conduct Risk Analysis process and document a risk based approach to the validation life cycle.

-Review and provide necessary input for validations from other departments in order to be compliant to regulations and company procedures.

-Design validation study features, such as sampling, testing, or analytical methodologies.

PROJECT Details: ACES NAAMS – Feb 2015 to Mar 2015, Validation Consultant in Sanofi (Cognizant Technology Solutions)

RESPONSIBILITIES:

- Ensure completeness and consistency of project life cycle documentation. - Analyze Requirements & Create test strategy, demands with business.

- Review and guide to design all testing and project deliverables. - Manage onshore & offshore validation testing team to perform system & regression testing. - Draft validation test plan, validation test summary report, quality and test deliverable. - Assist Compliance Manager to review all validation deliverables, route and follow-up for team approvals. - Own change control and release management process

PROJECT Details: Metrics Tool and Service Now Ticket Handling, - Apr 2014 to Jan 2015, PQM-Process Quality Manager (ETL QA) in Johnson &Johnson (Cognizant Technology Solutions)-ETL Informatica

RESPONSIBLITIES:

- Managing and tracking the day-to-day delivery to the client under the QMC – NLIT engagement

- Manage the financial forecast for QMC NLIT engagement; Track & Report the revenue to the cognizant management.

- Manage the resource forecasting and contracting for onshore and offshore team.

-Client business units coordination and provide Testing Process support to enable them to move to next level of Testing Maturity.

-Evaluate process improvement opportunities and implement process changes.

-Draft Compliance (Test) plan and Compliance (Test Summary) report, review all the testing deliverable.

-Provided Testing solution and GxP guidance to project team as per the corporate SOPs.

-Review all Test deliverables, identify the GAPs and provide solution to fix the GAPs.

-Managed GDP across all SDLC deliverables and ensured the compliance and process inheritance.

-Performed mock inspections and audits, identify the gaps, draft CAPA and provided solutions to fix NCs.

-Prepare quality metrics and present with project team for decision making.

-Responsible for ensuring timely execution of all projects, ensuring good client relationship and high customer satisfaction

-Interface with the offshore test managers at peer and senior levels to provide metrics, updates and details of Client expectations

-Ensure that test teams are meeting project objectives and timelines

-Help account team and Client with release calendar of projects ensuring resource needs are identified and met

-Work with management to identify solution line needs in terms of skills, roles and resource counts through estimation process

-Provide project status in the form of weekly status reports to QA/Test Director

PROJECT Details: Lamp Post (ANMIAS) - Jun 2012 to Mar 2014, QA Manager in Johnson &Johnson (Cognizant Technology Solutions) – ETL-Informatica-Cognos Reports

RESPONSIBLITIES:

- Develops detailed work plans, timelines, resource plans, project estimates, budgets, and status reports; leads project meetings and communication between internal and external teams.

-Be the single point of accountability for assigned projects

-Tracking and communicating project status, plans, issues, timelines, action items, and budgets.

-Worked with PMO, Leadership, Business, pharmacovigilance end users, Validation Testing Team, onshore QCSV, Change Controls, Release Management, offshore QSCV and vendors.

-Coordinated and guidance provided to SIT, Regression, UAT, Performance Testing & E2E Testing

- Promoting a proactive, professional culture within the Project Management organization, and contributing to the group’s success

-Understand the business and provided test strategy to design test deliverables, review and approve as per SDLC SOPs. Defect / Triage Coordination, design defect metrics for leadership escalation mechanism

-HPQC Setup and training to SMEs, Pharmacovigilance users, sales representatives and end-users.

PROJECT Details: AEGIS (Adverse Event Global Information System), MIR Reconciliation Report and LIR - Apr 2011 to May 2012 (ETL QA Manager), Validation Lead, Validation Manager in Abbott Laboratories (Cognizant Technology Solutions)

RESPONSIBLITIES:

Performed multiple projects and owned GIS division offshore point of contact, service continued with same projects at onshore and successfully tested and deployed in production.

-Managed Abbot GIS division testing projects from onshore & offshore.

-Manage external contractors, and third party vendors for validation projects

-Provide technical input in determining strategy for validation activities

-As a validation representative on change control committees and provide validation input on Quality Systems such as Quality Incidents & CAPAs

-Prepared and presented metrics (Quality & Testing) to leadership for decision making.

-Worked with senior management by involving new project proposals and estimations.

-Perform training on validation and other SOPs as assigned

- HPQC Setup and training to business SMEs to perform UAT.

-On site-Offshore coordinator for testing QA deliverable.

-Attending knowledge transfer sessions from client and presenting the reverse KT document to the client team.

-Monitoring Test Management and Defect tracking using Quality Centre.

-Defect Triage Coordinator for critical project tracks.

-Meeting with BA's and development team for defect triage process.

-Discussing QA team's queries with the business analyst. Daily Offshore team calls, status updates meetings.

PROJECT Details: Financial Testing Solution - Sep 2010 to Apr 2011, QA Manager in AAA Insurance (Cognizant Technology Solutions)

RESPONSIBLITIES:

The project is designed to ensure the performance of PeopleSoft billing and other ledger transaction to ensure the general Ledger balancing. It is to validate the financial and PeopleSoft related reports.

PROJECT Details: PITCoE – TRV - Jan 2010 to Aug 2010, Onshore QA & Offshore Test Manager in Travelers Insurance (Cognizant Technology Solutions)

Application designed to operate on the Personal Insurance - Package Policy Administration that includes Quoting, Rating, Issuing, Transaction Processing, and Policy Document Maintenance.

PROJECT Details: LN Sync - Sep 2008 TO July 2009, Test Consultant in MetLife, Inc (Cognizant Technology Solutions)

LN Sales Radar is Sync project is introduced to improve the current Sales Radar application with Lotus Notes synchronization process between Siebel application [Representative] and Lotus Notes.

PROJECT Details: SOX Testing Support - Sep 2008 TO July 2009, Test Manager in MetLife, Inc (Cognizant Technology Solutions)

The Sarbanes Oxley Act (SOX) testing project deals with helping the client to comply with the SOX regulation and other IT policies. Also help the client in testing the IT internal controls and prepare evidences for internal and external audit.

PROJECT Details: State Expansion - Aug 2007 to Aug 2008, Test Manager in CSAA Insurance (Cognizant Technology Solutions)

State Expansion project involves testing the Multico. Exceed product for Insurance functionality with respect to the Homeowners, Dwelling Fire, Motorcycle and Personal Umbrella Policies, based on the Underwriting guidelines of CSAA for the different states in US.

PROJECT Details: Pemco PI – Mar 2007 to Aug 2007, Test Lead in PEMCO Insurance (Cognizant Technology Solutions)

Exceed is an end -to-end Insurance Processing Solution which has the flexibility to incorporate modules like Policy Administration, Billing & Collections, Claims Administration, Document Solutions.

PROJECT Details: Athena Entitlements – Dec 2005 to Feb 2007 SQA in Thomson Reuters

The Athena Entitlement System implements the concept of Authentication and Authorization for customer. Scope of the entitlements based on SOX (Sarbanes Oxley) Compliance. MOPS- Market Order Processing system (Investments products portfolio Management).

- Design Test Scenarios and Test Cases for SOX Strategic Scenarios.

PROJECT Details: MOPS – Jul 2005 to Dec 2005 SQA in HCL Technologies (Thomson Reuters)

MOPS- Market Order Processing System - Athena-II Entitlement system is a consolidated web application; it consists of various sub-systems (like MOPS, B&E, BLOCK DATA, BETA LINK and TOPAS) exists in different environment.

PROJECT Details: Maxtrade – May 2005 to Jun 2005 Senior Test Engineer in ABN Ambro Bank (Maveric Systems) Investments experience with products and portfolio.

Maxtrade provides processing for various types of Letter of Credit (Import, Export, Stand By, Collection and Reimbursement). It is a multi-File of multi-location system that is used for regional centers in several International Locations. Good experience in

PROJECT Details: May2e Bank – Oct 2004 to April 2005 Test Engineer in Polaris (Maveric Systems)

The OrbiCash Bulk Payments System allows May bank’s corporate customers to electronically submit Salary files and track the status of their payments. The system processes these transactions based on the Payment modes and manages the life cycle of the Payments transactions.

PROJECT Details: Am Bank – Aug 2004 to Oct 2004 Test Engineer in Polaris (Maveric Systems)

OrbiDirect (Front-End, Back- End), Cash Core Maintenance, Payments, Maintenance, Cheque, Charges and Reports. The Products (Payment Modes) used by AM Bank for Fund Transfer are Internal Fund Transfer (IFT), GIRO and RENTAS

PROJECT Details: CBT – Feb 2002 to Aug 2004 Test Engineer in Tiara Techtronics

Design & Test Computer Based Tutorials for multiple software platforms designed for educational services.

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