SAGAR PATEL

Validation Engineer

OVERVIEW:

Strong business, planning, validation, implementation encompassing the

complete lifecycle of a project - design, development, testing, validation,

deployment and support - with strong focus in Manufacturing and Production

Planning applications, and ERP Validation in Pharmaceutical and Life

science industry.

PROFESSIONAL SUMMARY:

. Over 6 years of experience in IT including three years of experience in

Quality Assurance, Computer system Validations, 21 CFR part 11

Compliance.

. Significant Technical/Quality Assurance/Project Lead experience in

planning, designing, implementing, measuring, and improving IT

infrastructure projects.

. Extensive working knowledge on Validation Life Cycle.

. Extensive hands on experience and knowledge of Food and Drug

Administration (FDA) regulations (particularly 21 CFR Part 11/ 210/ 211/

820) qualification-testing protocols (IQ, PQ, OQ).

. Experience in GxPs (GMP, GCP, GLP). Validation process and QA Strategies.

. Performed Independent Validation and Verification testing to test credit

approval modules.

. Understanding of Industry standards like ISO 9000/01, CMM, Six Sigma.

. Understanding of SDLC cycle and different methods and AGILE principles.

. Good mentoring skills, analytical skills, presentation skills with strong

communication skills.

. Diligent worker, self-starter and consistent performer.

. Adaptable to work as a team member and also independently.

. Ability to work autonomously as well as Team and project management

experience.

. Working knowledge of MS Office, MS Visio, MS Project.

. Demonstrated record of success in applying QA methodologies and

compliance solutions to clients' specific needs on Systems and GMP

Procedures.

. Excellent Technical Writing and Communication Skills.

. Good Project Management Skills.

TECHNICALSKILLS:

Validation 21 CFR Part 11, cGXP (cGMP, cGDP, cGLP), GAMP, GCL GPV Quality

System Regulation (QSR), Audit Trails, Standard Operating

Procedures (SOP's), Gap Analysis and Remediation, Validation Plan

and Protocols, Configuration Management, RTM, Risk Analysis

Testing Tools HP Quality Center, Quick Test Professional, Win Runner, Test

Director

Application Documentum, SAS

Software

Databases Oracle, MS Access, SQL Server 2000

Operating Systems Windows 2012/XP and UNIX

Languages SQL, SAS, SPSS, Oracle EBS, ERP, SAP and CRM

Business Tools MS Office Suite 2010, MS Project and Visio

EDUCATION

Master's in Public Health

TRAINING:

Regulatory Requirements: HIPAA, ISO9001 Part I, ISO9001, FDA Quality

System, 21 CFR Part 11, 820 Risk Management.

PROFESSIONAL EXPERIENCE:

PPD, Morrisville, NC Dec 2015 - Present

Validation Consultant

Project: Validation of Argus data system. Argus is web-based adverse event

software solution that enables the collection, assessment and reporting of

adverse event information to the global regulatory agencies. Argus ensures

compliance with international adverse drug event reporting obligations,

providing expedited and periodic aggregate reporting while tracking KPIs

and other critical metrics.

Environment: Argus, Crystal reports, Agile

Responsibilities:

. Managed CSV of Argus safety system upgrade from v3.x to v5.x, right from

requirements gathering to Production release.

. Developed the validation plan

. Involved in developing user and functional requirements of Argus -

adverse event system.

. Requirements gathering and analysis, business analysis, Risk assessment

and requirements specifications

. Documented the configuration specification of Argus

. Developed functional requirements and assisted in the development of

Design Document.

. Worked as a team member supporting the development and approval of

validation deliverables and protocols.

. Responsible for developing IQ, OQ and UAT protocols for Argus

implementation.

. Developed workflow, and security specifications, and RTM document.

. Responsible for Test Plan, Testing activities. providing support to

development and testing teams

. Verification, clarification and sign-off of the functional

requirements/functional specification.

. Assisted in execution of IQ, OQ and documentation of Test and Validation

reports, deviations, and final sign off on the UAT test scripts.

. Co-ordinated and managed system issue tickets post go-live.

. Played a key role on project issues such as release management, change

management, and scope control.

. Involved in the summary report activities.

Gilead Sciences, Foster City, CA May 2015 - Nov 2015

Validation Engineer

Project: The project aimed at creating a File share access clean up drive

where all the clients in the Active directory were to be contacted and

their information was retrieved based upon whether or not they still

existed in the company. Another part of the project aimed at testing of

Gilead's applications using an in house tool and also performing validation

on the system.

Environment: Track wise, Linux, Apache Web server, Crystal reports, Track

wise, Agile, Oracle

Responsibilities:

. Developed Validation Master Plan (VMP) in compliance with SOPs and FDA

regulations

. Documented test execution report for TrackWise and prepared Requirement

Traceability Matrix (RTM)

. Involved in auditing the application for 21 CFR Part 11 compliance

related to Electronic Signatures and Electronic Records for TrackWise

System

. Developed Crystal Report templates for TrackWise and single / multiple

reports for adverse events

. Developed test scripts and test cases for automated and regression

testing using HP Quality Center

. Prepared and reviewed Validation Summary Repot (VSR) to summarize the

overall validation effort

. Finding defects & tracking them by using Quality Center and Rally for

TrackWise

. Assisted the Project Manager in preparing Incident Reports as a part of

testing process

. Created traceability matrix, and validation summary Report.

. Testing oracle apps testing, designing test plans and execution,

understanding client requirements and mapping

. Responsibilities includes Business Requirement Gathering, Requirement

Mapping, GAP analysis, Functional Design, Proof of Concept, Unit Testing,

UAT and User Training

Celgene Pharmaceuticals Inc, Summit, NJ Oct 2014 - April 2015

Validation Specialist

Participated in four projects - Validation of GLP systems as part of new

pilot plant for clinical supplies as part of R & D. The R & D laboratory

systems associated with the pilot plant must be validated and needed to be

updated to Windows platform.

Environment: HPLC Laboratory System, SAS tool

Responsibilities:

. Validation of HPLC laboratory systems.

. Validation Plan for similar 6 HPLC systems of laboratory systems which

were integrated with Empower.

. User and functional requirements with Part 11 Functionalities

. Responsible for testing strategy, Test Plan, Protocol, IQ, OQ, PQ, RTM

and Validation Summary.

. Plan the validation effort based on risk assessment and regulatory

assessment.

. Provided inputs for writing Computer Work Instructions.

. Validation of Total Organic Carbon Analyzer TOC laboratory systems.

. Responsible for User and functional requirements with Part 11

Functionalities.

. Responsible for Test Plan, Protocol, IQ, OQ, PQ, RTM and Validation

Summary.

. Validation of FTIR, UV/V is laboratory systems.

. Authored the deliverables- Validation Plan, Requirement Specifications,

Test Plan and Protocol, Requirement Traceability Matrix (RTM) and

Validation Summary Report

. Periodic Review of various laboratory and enterprise systems.

. Review Performance Monitoring Plans, Quarterly Performance Monitoring

Summary Report.

. Review Validation deliverables, Change Control Logs, Production Log,

Event Log, Platform Log, Database Change Logs.

. Performed Risk Assessments.

. Review SOPs / Computer Work Instructions (CWI) / Laboratory Equipment

Procedures (LEP) against business use, local policies / procedures and

regulations.

. Review user training log, user log, user manual, technical support

manual, calibration records and preventive maintenance records.

. Summarize the review and recommendations in Periodic Review Report.

. Performed Periodic Review on Ab Initio (Data Warehousing tool), SAS Tool,

Excel Spreadsheets, Spectrophotometers, Particle Size Analyzers

Olympus Medicals, Center Valley, PA Feb 2013 - Oct 2014

SAP QA / Validation

ECC 6.0 Global implementation across 4 process areas

Environment: SAP ECC 6.0, LIMS

Responsibilities:

. Integrated with the executives and the PMO to develop time lines, Test

Practices Process and Procedures/Standards, Test Case and Defects

Reporting Process Procedures, Master Test Plan Strategy and Criteria for

Technical, Functional, Integration, Performance, User Acceptance Testing

(UAT) and Regression Testing.

. Developed Master Test Plan for SAP streams - Procure to Pay, QM, Order to

Cash and Monitored the unit tests for the RICEFS conducted by the off-

shore teams on a day-to-day basis, conducted daily review meetings for

the identification, classification of issues and bottlenecks.

. Designed -review and approval process work flows in Solution Manager for

documents and in HPQC for defects and Change Management.

. Authored data migration plan and was instrumental in data uploads.

Developed Integration Test Plan and Configuration and Change Management

Plan and managed Patch releases for Solution Manager.

. Worked as a team with P2P test teams each consisting of 1 functional SME

and 3 testers - offshore Including interface with Labware LIMS systems

with SAP.

. Reviewed approved the interface integration of MES system Flex-Net with

SAP -both specifications and testing.

Meditab Software, Ahmedabad, India July 2012 - Jan 2013

Validation Engineer

Meditab combines in-depth knowledge of healthcare processes, system

installations, and training with the most comprehensive range of solutions,

support, and services available. Meditab Software, Inc. provides an

innovative suite of intelligent, integrated and intuitive Software

Solutions supporting the primary process of healthcare delivery. Based in

northern California, Meditab revolutionary software solutions connect

physicians, patients, labs, pharmacies and long-term care facilities

nationwide.

Environment: Track wise, Agile, Oracle

Responsibilities:

. Reviewed the configuration documents and Installation qualification pre

execution.

. Assisted in writing Operational Qualification test scripts including

those for Audit Trails and e-Signature

Pre UAT dry run of OQ scripts.

. Supported in formal OQ execution and deviation management process and

validation paper document archival.

. Involved in preparing all Validation documents including Risk Assessment

Report, Validation Plan and Report, and Requirements Traceability Matrix,

IOP/Q Protocols (excluding the IOP/Q test scripts), IOP/Q

. Reviewed SDLC deliverables relevant to Validation including Business

Requirements, Training Plan and Oracle Admin and Business process SOPs.

. Reviewed and approved IOP/Q scripts pre and post formal execution

including OQ dry runs

OQ and PPQ Test Execution Management.

. Interface with NTT Data implementation team and Ultragenyx IT, Validation

and QA on all project validation touch points.

. Prepared and reviewed Summary Reports, Data Migration Plan and Summary

Report, Business and QA Release memo, and Final preparation of Validation

package for document archival.

Hetero Drugs Ltd., Surat, India Sept 2010 - Jun 2012

Validation Engineer

The company manufactures generic pharmaceuticals and active pharmaceutical

ingredients. The company's area of activity includes six major

therapeutic/product areas: antibiotics, anti-retrovirals, cardiovascular

products, central nervous system products, gastroenterologicals, and anti-

allergics.

Environment: CAPA

Responsibilities:

. Provided validation services for manufacturing facilities, packaging

equipment, utilities, computer systems and laboratory instrumentation, in

addition to cleaning validation.

. Authored Test protocols/reports for validating the existing tests within

the process, including Installation, Operational and Performance

Qualification (IQ/OQ/PQ) protocol/reports for the manufacturing

machine/equipment.

. Assisted with cause-identification and problem-resolution for various

types of issues.

. Participate in audits as process and quality systems subject matter

expert.

. Root cause analysis and CAPA follow ups.

. Demonstrate ability to make consistent and data driven decisions.

. Comply with ISO standards and requirements.

. Performed timely studies, Gage R&R and capability studies (Cpk) on new

process/products.

. Interaction with Business Owners, System Owners, Business Analyst and

Technical Writers.

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