Project Management

ManpreetKaur

Employer:Kani Solutions, Inc.

Contact Person: srikanth

Contact # 443-***-**** X 1003

Email: ********@*******.*** VALIDATION ANALYST

SUMMARY:

Validation Analyst with around Seven years of work experience in Pharmaceutical and

Biotechnology industries focusing on Computer System Validation, Software Quality

Assurance,Business analysis, Requirements Gathering, Data Analysis, Technical documentation

and generation of user specific reports.

COMPETENCIES:

Applications:

• Electronic Adverse Events Management System

• Electronic Data Management Systems (EDMS)

• Clinical Data Management Systems (CDMS)

• Argus

• Labware LIMS

• Electronic LabNote book (ELN)

Pharma Industry – Business:

• Review of Lifecycle documents, Assessments, Qualification Protocols, and Summary

Reports including, but not limited to:

Quality Plan

User Requirements Specification

Functional and Design Specification

Functional Risk Assessment

Parameter Validation Assessment

IQ,OQ, PQ Protocols

Summary Reports

• Pharmaceutical Project Management

• Clinical Information/Data Flow

• Change Management

• GxP Standards

• Process Reengineering/Training

• Publishing process

• Coordination of FDA inspections

• 21 CFR Part 11 compliance activities

Pharma Industry – Information Technology:

• Front End Reporting, Dataware Housing

• Mercury Quality Center, QTP

• Clinical data capture, processing & SQL for reporting

• Ad hoc query and reporting tools

• Support & Maintenance

• Systems development

• SDLC/Validation/21 CFR Part 11

Pharma Industry – Training:

• FDA Regulations and guidance: 21 CFR Part 11- General Awareness, FDA Guidance for

Software Validation, FDA Guidance of COTS validation.

• GAMP Standards and V-Model as system development life cycle.

• Computer System Validation.

• Inspection Readiness Program

• Good Clinical Practices

PROFESSIONAL EXPERIENCE:

Taro Pharmaceuticals, Hawthorne, NY Jan 2014 – Present

Validation Tester Lead

Managing team of 8 members for the project involved IQ/OQ/PQ validation testing of Metis

system as per FDA regulations. It’s a system which provides supply chain management,

warehouse management and inventory management solutions. It’s a tool for NEC and having

AS400 server with EDI based.

Responsibilities:

• Responsible for identifying gaps and recommending solutions to software validation

processes, procedures and practices

• Ensure accuracy and completeness of software validation records like validation Plan,

installation qualifications, operational qualifications and performance qualifications

• Responsible for executing the validation plan and methodology for SCM, WMS, IMS.

• Handle the tasks of implementing high level and detail test specifications, test plans, test

cases and scripts

• Provide expertise in the review of all deliverables across the product life-cycle, ranging

from documentation, high level/detailed design, code deliverables to packaged solutions

for release

• Perform validation activities, general system testing, stress and stability testing

• Draft test results in a structured way and report on product quality to project management

• Reviewing, recommending, and implementing process improvement techniques to

increase test quality and improve test productivity.

Medtronic Inc., Memphis, TN June 2012 – Dec 2013

Sr. Validation Analyst

Medtronic is the world leader in medical technology providing lifelong solutions for people with

chronic disease. My project included validation of Oracle (AERS) Adverse Event Reporting

Systemfrom BioPharm Systems in compliance with FDA rules and regulations. AERS is a post

marketing safety surveillance system that keeps records for all the approved drugs and biological

products.

Responsibilities:

• Involved in preparation of Validation Master Plan (VMP)

• Developed FDA compliance documentations

• Prepared Standard Operating Procedures (SOPs) according to required specifications

• Involved in documentation during various stages of AERS validation lifecycle, in

accordance with FDA regulations

• Provided status updates for the project as per the management requires

• Developed validation and quality assurance programs including templates for validation

related documentation such as Validation Protocols, Installation Qualification (IQ),

Operational Qualification (OQ), Performance Qualification (PQ)

• Foster communication and cooperation between QA team, software quality, software

development, information technology, software support teams and the user community.

• Involved in documentation of Validation Summary Report (VSR)

• Actively participated in project meetings and reviews.

MYLAN LABORATORIES, INC., PA May2011 – May 2012

Validation Lead

Engaged by Mylan Pharmaceutical Company as Validation Lead to implement, support and

manage development activities for computerized systems used in safety and related regulatory

affairs such as Argus. These systems are responsible for providing safety investigator reporting

and/or analyses as required by the Food and Drug Administration (FDA) and other regulatory

bodies.

Responsibilities:

• Developed the Validation Master Plan for Argus Drug Safety Software.

• Developed IQ, OQ and PQ for instrument applications.

• Participated in all the phases of SDLC and involved in creating Validation protocols.

• Provided support to Argus safety suite i.e. Argus/ArgusJSafety Suite and their interfaces

covering case processing, triageand routing, E2B expertise and development.

• Data migration framework for migrating Legacy Data to Argus Safety

• Involved in Argus Safety Implementation and Up gradation Path from V 6.0.1.x to 7.0

• Workedon Phamacovigilance systems support and maintenance

• Provided GAP analysis on incomplete SOPs, and added the required SOPs.

• Prepared medical safety sections in safety alert reports, clinical protocols, investigator

brochures, clinical study reports,other medical/safety documentation.

• Participated in the documentation review process and Document Review sessions.

• Implemented CRs or new functionality in customer Argus safety environment.

• Reviewed and developed Requirements Traceability Matrix (RTM).

• Involved in preparation of configuration documents in accordance to company standards.

• Assisted the team with Validation Summary Report and release of instruments for

production.

• Worked with Mercury Quality Center to update, report on, and maintain Test Sets.

• Worked with Oracle Clinical Validation suite to obtain a comprehensive view of

important clinical data.

• Develop the QTP test automation and deliver for regression testing. Facilitate

automated test execution using Quality Center, HCQC, create test batch and automated

execution schedules. Assure test data, schedule automated/manual tests and using utilities

such as HCQC.

• Review Validation Deliverables from the QA perspective using pharmaceutical GxP

practices.

• Conduct QC of final project Validation Deliverables, electronic version and hard copy

version.

• Recommend areas for remediation and review action plan.

Actavis, Elizabeth, NJ April 2010-April2011

Validation Analyst/Business Analyst

The project involved customization and validation of LabWare LIMS as per 21 CFR Part 11.

Guidelines were prepared for the integration and validation of new laboratory instrumentation in

compliance with cGxP and validation documentation.

Responsibilities:

• Validated the process to comply with the FDA rules and regulations.

• Participated in SDLC planning, implementation and documentation.

• Developed SOPs for Validation Plan, Test Cases and Test Procedure.

• Reviewed validation deliverables such as VMP, Validation Protocols, and VSR.

• Helped qualify the terminals and machines for optimal configuration using IQ and OQ.

• Used the audit trail mechanism to monitor all activities and data transactions and storing

these activities.

• Performed vendor audits, laboratory audits and general cGMP compliance audits.

• Attended training sessions on GDPs (Good Documentation Practices) that have to be

followed as a part rigorous System & Integration Testing.

• Involved throughout the testing and documentation phase of the Computer System

Validation project.

• Managed system upgrades, enhancements, and maintenance in a cGMP environment

• Documented Test Scripts to check for compliance with 21 CFR Part 11 rules of the FDA.

• Performed GAP Analysis and developed the corresponding Remediation plan.

• Conducted UAT to make sure that all the user requirements are met and maintained

communication with team members, stake holders.

• Validated the Electronic Records and Electronic Signatures in accordance with the

FDAguidelines.

JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT, FL

January 2009 - March 2010

Validation Analyst

Assigned to the Clinical Trial System Application, which enables the users to manage the drug

trials process and efficiently bring new treatments and product through predefined FDA process

to market.

Responsibilities:

• Conducted review of Development Team design level validation deliverables using

pharmaceutical GxP standards and implemented the 21 CFR Part 11.

• Used Mercury Quality Center for integration with QTP automation tool to generate the

test reports.

• Involved in development of Validation Master Plan.

• Performed GAP Analysis, identifying SOPs and functionalities to be included.

• Involved in reviewing and writing URS and Functional Requirements.

• Revised the system SOPs for the current business practices.

• Developed protocols IQ, OQ, PQ and assisted in execution.

• Assured that all validation deliverables are in compliance with SDLC and implemented

the XML schema DTD for document that contains an undefined element in Front End

Reports.

• With EMDS, integrated document management directly into other applications, so that

users may retrieve existing documents directly from the document management system

repository for the EDNA.

• Automate test cases using Win Runner and QTP. Develop reusable function library and

object repository.

• Supported development of Design Level Quality Plan.

• Development of a Design Level Validation Plan and Summary Report.

Cubist Pharmaceuticals, Lexington, MA June 2007 -Dec 2008

Validation Leader

Served as validation Leader, Managing testing team of 5 people

Responsibilities

• Involved in Remediation compliance validation of Legacysystemand Retirement

Process Plan.

• Created Inventory list of systems that needs assessment.

• Conducted interviews with System Owners to ensure the validity of the systems.

• Assisted with business case high-level feasibility, gather and define business

requirements and analyze and map process, analyze data.

• Process change requests and trace requirements during implementation.

Performed System validation before the commencement of the Validation process.

•

Generate remediation plan to cure the system(provided requirement, H/W, S/W, SOPs, 21

•

CFRpart11 criteria, interface information).

Worked on 21 CFR Part 11 assessment and GMP assessment to find the compliance

•

gaps in the system.

Liaised with other project areas to coordinate interdependencies and resolve issues.

•

Create Assessment Summary report to detail the gaps of the system.

•

Involved in creating Remediation Plan for many systems to resolve the Compliance

•

gaps.

Worked with System Owners to discuss the Remediation plan, the schedule and Budget

•

involved in Validation.

Clearly identified closed and open systems according to 21CFR Part 11.10 and 11.30.

•

Checked whether the execution of the e-signs are Audit trailed

•

Used authority checks to ensure that authorized individuals can enter sign or change

•

data. Audit Trails, preparation of Traceability matrix.

Tested for signature manifestations in compliance with 21 CFR Part 11

•

Contact this candidate