Quality Assurance Project Manager

SA

Summary

* ***** ** ********* ********** as Validation, Verification, GMP Compliance

and Quality Analyst Engineer in diversified industry sectors including

Pharmaceutical/Bio-Pharmaceutical, Manufacturing and Medical device.

Expertise in Computer Systems Validation (CSV) SDLC and Quality Assurance

as per FDA regulations including working knowledge of FDA predicates (21CFR

Part 11, 203/210/211/820/1271), GMP, GLP, GCP, GDP and GAMP.

Extensive experience in Prospective, Concurrent and Retrospective

validation.

Proficient in Validations, Quality, Regulatory Compliance, Commissioning,

Qualification, FDA regulation, cGMPs, GxP and CV and Kaye Validator 2000.

Good experience in performing cGMP audits, change control program, and GAP

Assessment for equipments, utilities, facilities and laboratory

validations. Certified in Root Cause analysis and CAPA Investigations.

Expert at QSR's, ISO 13485, 21 CFR 11, GAMP, SDLC methodologies, CAPA and

ITIL.

Familiarity with software lifecycle in a regulated environment

(ISO9000/FDA).

Conduct validation activities in compliance with QSR820.75 and GHTF

Requirements and Precision Edge Surgical Procedures.

Good experience in Statistical Process Control (SPC), Design of Experiments

(DOE) and process validation activities.

Execute validation protocols as needed (Equipment IQ/OQ, Software IQ/OQ,

Process OQ, Process PQ etc.).

Understand and follow SOP's and DOP's. Follow and comply with GMP, GLP and

FDA guidance.

Involved in understanding of CAPA and its related processes.

Good experience and knowledge of FDA and ISO requirements and Validation

Documentation Practices, with Process Validation/Test Method Validation

(including process development capabilities), Equipment

Qualification/Computer Systems Validation (CSV) and Cleaning Validation.

Remarkable experience with FDA Design Control regulations, GUI, automated

testing tools.

Profound knowledge of software verification and validation approaches.

Familiar in reporting to the upper management about the progress of the

CAPA's and its final status.

Good in validation documentation as required (plans, protocols, reports,

procedures etc.).

Proficient in Regulatory Submission documentation and Document Management

System (Documentum) experience.

Knowledge of DOORS in managing the documentation work as well in importing

the test cases to the spreadsheet

Familiar with CAPA according to the GMP requirements.

Good knowledgeable in ISPE Commissioning and Qualification Guidelines. Have

developed and implemented qualification master plans, impact assessments,

test plans, SOP's, and commissioning and qualification protocols.

Can able to generate, follow and explain detailed quality and validation

requirements.

Knowledge in Maximo Asset Management during transportation, production of

IT and validated deliverables.

Well versed with Software Development Life Cycle (SDLC) methodologies with

emphasis on quality assurance and testing practices.

Excellent analytical and reporting capabilities with preference for

expansive knowledge of Minitab Release 15 for Process Validation Engineers.

Proficiency in Defect management, including Defect creation, modification,

tracking, reporting using TestDirector/Quality Center/ALM.

Good working knowledge of MS-Office (Outlook, Express, Word, Excel and

Power point).

Experience in specifications and modifications to meet and exceed customer

requirements, needs and objectives.

Maintaining laboratory records, include test plans, test results and defect

capturing.

Technical Skills

Compliance: FDA regulations, 21 CFR Part 11, cGxP, ICH

guidelines, DOORS, Audit Trails

Computer System Validation: 21 CFR Part 11 (210/211), GAMP, cGxP, IQ, OQ,

PQ, SOP, Summary Reports

Documentum: IQ, OQ, PQ, VMP, GAP analysis, CAPA, RTM, TSR, QA, FRD,

Compliance reports

Pharma Systems: ARISg Total Safety Suite, SQL*LIMS, Virtx SPL,

QTS Trackwise

Testing Tools: TestDirector/Quality Center/ALM, ClearQuest,

unit testing, integration testing,

Regression testing,

performance testing, UAT.

Process Simulation: Aspen, Hysys

Chemical Related: ASPEN PLUS, Mat lab, MathCAD, CHETAH, Chemdraw

Operating Systems: Windows 2000/XP/Vista/8, UNIX

MS Office: MS Word, MS Excel, MS PowerPoint, MS Access, MS

Visio

Professional Experience

Takeda Pharmaceuticals, Deerfield, IL Apr '12-

Till date

Validation Compliance specialist

Responsibilities

Involved in all phases of Computer System Validation (CSV) Life Cycle to

comply with FDA regulations particularly 21 CFR Part 11.

Responsible for authoring and reviewing Standard Operating Procedures

(SOPs), URS/FRS, DS, Risk Assessment, IQ/OQ/PQ Protocols, Deviation

Management, Traceability Matrix and Validation Summary Report.

Documented Requirements Traceability Matrix (RTM) to track the

requirements.

Involved in performing Risk Assessment and proposed improvement suggestions

on Validation processes.

Responsible for the Quality review of all Validation and Engineering

Qualification protocols and reports for adherence to cGMPs, good

documentation practices, and general quality oversight.

Created, modified, maintained, archived and retrieved electronic records to

be submitted to FDA for inspection.

Testing software databases including data migration and load testing

Schedule test execution, analyze test results and prepare test reports.

Responsible for developing Standard Operating Procedures (SOPs) referring

to 21 CFR Part11 for LabWare LIMS (Laboratory Information Management

Systems).

Configured modules and gathered requirements for the LabWare LIMS.

Test cases are imported from excel sheets to Quality Center.

Worked with Engineering and Validation areas to coordinate execution

activities and to resolve compliance issues.

Worked closely with engineering disciplines during design phase conducting

cGMP design reviews and development of the Validation Master Plan.

Additional responsibilities included development of protocols (IQ/OQ/PQ).

Performed Validation Testing on the application in accordance with FDA

guide lines.

Involved in preparing Validation Strategy Document (VSD).

Reviewed User and Functional Requirement Specification (UFRS), Requirements

Traceability Matrix (RTM) and IQ/OQ/PQ Scripts.

Responsibilities included IQ, OQ, IC (Installation Commissioning), and OC

(Operational Commissioning), writing and execution, review of turnover

packages, and assistance in the resolution of deviation notices.

Executed the test cases and tracked defects in Quality Center.

Generation, execution and close-out of deviation reports and protocol

amendments.

Assist in the review of PQ deviations. Generated and maintain the project

schedule to comply with client critical dates and manufacturing areas

requirements.

Review and approve all qualification documents like Test Plan,

Requirements, Test Cases (UAT, system tests).

Worked in the area of MAXIMO in change control management of validation

deliverables.

Verify receipt of approved documentation according to the Client

requirements.

Coordination of Project Meetings and presentation of project progress.

Stryker (Medical Devices), Kalamazoo, MI

May '10-Mar '12

QA Validation Analyst

Responsibilities

Responsible for creating and executing protocols, requirements traceability

and reports in accordance with company SOPs, project plan and product

specifications.

Determine validation requirements for processes. This includes validations

related to new product launches, new equipment, re-validation associated

with change control, and validation of existing equipment to meet

regulatory requirements.

Involved in authoring, reviewing and approving various Validation

Deliverables (e.g. Validation Plan, SOPs, URS/FRS, IQ/OQ/PQ Protocols, Test

Scripts and Summary Reports etc.).

Monitor and maintain listings of validation records and ensure that records

are adequately defined, complete, and archived.

Worked with Project manager on scheduling completion and approval of

validation deliverables.

Developed Validation Master Plan, Test plan, User Requirements, Risk

Assessment Documents, Design Requirements, IQ/OQ/PQ, RTM, Validation

Summary Reports, and Master Validation Report

Analyzed and documented the test results for each build of testing.

Manages the preparation of study documentation packages, which include data

review and summary of each assessment for presentation to management and

regulatory agencies, ensuring compliance with cGMPs.

Developed listing of required quality records and ensure that records are

adequately defined, complete, and archives.

Involved in CAPA report writing in accordance with QMS

Involved in developing detailed test plan, test cases and test scripts

using Quality Center for functional, security and regression testing.

Development of Master Validation Plans and ensuring that the plan

requirements are fulfilled including timelines.

Updating and refining the validation template system for streamlining

validation implementation.

Define validation completion and change control performance measures and

implement trending for long range goals and plans for continuous

improvement.

Assist in identifying risks and conducts risk mitigation testing.

Maintaining Defect logging and closure according to SOP.

Performed Gap Analysis and compliance audits on existing

operations/documentation and supporting the client's development of a

remediation plan to address the deficiencies.

Assisting and conducting compliance assessments, equipment qualification

and validation. Assisting in the development of SOPs, preventive

maintenance, systems integration, and change control.

Work with clients to evaluate systems and operations for compliance against

both internal policies and FDA regulatory compliance.

Coordinated meetings with upper management to discuss project status and

progress.

Zimmer OSP (Medical Devices), Dover, OH

Apr '09-Mar '10

Validation Analyst

Responsibilities

Performed the evaluation and recommendation to the CAPA team to analyze and

investigate CAPA's.

Developed the tracking tool used to monitor the progress of all the CAPA's

being addressed.

Report to the upper management the progress of the CAPA's and the final

status.

Worked with vendors and users to collect and document user requirements.

Involved in providing continuous Quality Assurance in improvement efforts.

Developed Validation Master Plan (VMP), Validation Protocols in compliance

with FDA regulations.

Wrote and implemented Test Plan, various Test Cases and Test Scripts.

Involved in validating the CIP systems of pasteurization and autoclave re-

qualifications.

Involved in developing manufacturing SOPs based on cGMP.

Involved in GAP Analysis for user requirements verification and diverse

Remediation Plans to avoid project deviation.

Documented all the steps in accordance with 21 CFR Part 11, Part 820 and

cGMP.

Cleaning and sanitization of chromatography, ultraviolet visible

spectrophotometer, cold rooms, incubators, centrifuges, bioreactors and

spectrophotometers.

Performed Risk Analysis on the basis of user requirements.

Extensively used Quality Center (QC) for reporting bugs and tracking

testing progress.

Contributed to project review meetings and walkthroughs.

MedImmune, Gaithersburg, MD Jan '08-

Mar '09

Validation Engineer

Responsibilities

Generate, review and support deviations corrective plans. Work directly

with Engineering and Validation areas to coordinate execution activities

and to resolve compliance issues.

Generation, execution and close-out of deviation reports and protocol

Amendments.

Involved in preparing documentation for all aspects of the computer system

validation lifecycle, in accordance with FDA regulations, particularly 21

CFR Part 11including IQ, OQ and PQ specifications.

Maintained and documented SOPs.

Wrote and implemented Test Plan, various Test Cases and Test Scripts.

Responsible for calibrating, troubleshooting and maintaining the laboratory

equipments including GC, HPLC, spectrometers, autoclaves and pH meters.

Involved in developing and implementing the test strategy and performed

various analyses.

Regular interaction with Designers, Developers and System Analysts.

Analyzed the requirements and critical areas of the application to setup

and execute baseline tests.

Performed GAP Analysis, Remediation Plan and maintenance of hybrid systems,

closed and open record systems.

Drafted SOPs and trained users on these systems and the implications and

impact of 21 CFR Part 11 compliant data systems on the day-to-day

functions.

Involved in preparing compliance report about existing status of cGMP, cGCP

and cGLP.

Dr. Reddys Labs, Hyderabad, India

Apr '06-Oct '07

Process Engineer

Responsibilities

Verified and validated System security, Authority Checks, Operational

Checks for Waters Empower, SoftMax and Agilent ChemStation compliant with

ISO regulations.

Qualified Chromatography (HPLC, GC, LC/MS) sequence data and reports on

samples, for accuracy, clarity and traceability.

Followed the Standard Operating Procedure (SOP's) of the company in

documenting Test Plan, Test Cases and Test Procedure using Business

Requirements Document (BRD) and Functional Requirements Document (FRD) of

the system.

Involved in writing and execution of qualification protocols like IQ, OQ

and PQ.

Maintained Traceability Matrices for mapping the requirements to the test

cases.

Conducted User Acceptance Testing (UAT) before the initial release when the

project reached the final phase prior to deployment.

Actively participated in preparing the Test Summary Report (TSR).

Developed QA documentation for the ISO audits.

Education:

Bachelor's in Pharmacy from JNT University, India

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