Quality Assurance Management

Namitha Murthy, PMP

*** ******** ******, ***** ***** Brook, New Jersey 08880

*************@*****.*** Phone: 732-***-****

PROFILE:

9.9 years of experience in the Pharmaceutical industry including Strategic

consulting, Project management, Serialization implementations, Security,

Risk, Compliance and Quality management in Application Outsourcing, GxP

Validation, GCP Quality Assurance, Regulatory Inspection readiness, People

management, Business development, Clinical operations, Clinical research

monitoring.

Clientele include: J&J - USA, Pfizer - USA, Merck - USA, AstraZeneca - UK,

Wyeth - USA (Currently Pfizer), Organon - USA (Currently Merck & Co), Dr.

Reddy's - India

CERTIFICATIONS:

Project Management Professional (PMP), Certified through Project Management

Institute (PMI); 2013

GCP auditing- British Association of Research Quality Assurance (BARQA),

Cambridge, UK; Mar 2007

PROFESSIONAL EXPERIENCE:

NORTH HIGHLAND, Princeton, NJ

Oct 2013 to Present

Manager - Management Consulting

Responsible for General management consulting for both public and private

sector organizations, responsibilities include deploying best practice

solutions in support of organizational excellence and team accountability,

Process improvement and Project management.

- Responsible for overall project management which includes managing and

scoping projects, problem solving, client management, identifying and

managing project dependencies and critical path

- Understanding client business issues, operating business rules to

incorporate process changes in response to evolving business needs

- Developing and delivering progress reports, proposals, requirements

documentation, and presentations

Selected sample engagement:

Developed Strategic Sourcing approach for a $150 M program to determine

which model best supports client's expectations regarding quality and

oversight for outsourced clinical studies - played the role of a Project

liaison working with senior clients across work streams.

- Defined project scope, developed project charter, project plans and

deliverables that support client's business goals in collaboration with

project stakeholders

- Executed in-depth assessments to leverage data from 2 studies to

determine if additional clinical trials could use the sourcing approach

- Performed Gap Analysis to eliminate any risks

- Performed qualitative and quantitative data analyses to determine the

level of oversight that client will need to employ (time, resource) and

determined the IT infrastructure needs.

ACCENTURE, New Jersey, USA

Jan 2012 to Oct 2013

Associate Manager Serialization Implementation Lead

Nov 2012 to Oct 2013

Project Management and Process development

- Lead and supported the implementation of serialization on product lines

by aligning supply chains to Business Technology

- Defined and initiated projects, assisted warehouse Project Managers to

manage schedule and performance of component projects, while working to

ensure the ultimate success and acceptance of the program

- Liaised with Subject Matter Experts in Serialization, e pedigree,Track

and Trace to develop Business User requirements and workflows

- Built credibility, establish rapport, and maintained communication with

clients at multiple levels

Associate Manager - GxP Compliance

Jan 2012 to Nov 2012

Responsible for Quality Management, Security, Risk and compliance in

Integrated Services for an US based Pharmaceutical Company.

- Experience includes review of Software Delivery Life Cycle(SDLC)

deliverables in FDA regulated environment with good understanding of cGxP

(cGMP, cGDP, cGAMP, cGLP) standards

- Implemented QA Methodologies; facilitated transition of QA activities

from other client partners, built and implemented QA tools to support

SDLC reviews

- Coordinated the Accenture Client Data Protection Program and Business

Continuity program for the project

- Assessed Regulatory and Compliance requirements focusing on Information

Security,participated in Security, Risk and Governance meetings with

Client and other client partners.

- Training compliance - Liaised with the client to understand the training

needs,designed training programs, produced organizational strategy and

plans to meet training and development needs.

ACCENTURE Services Pvt. Ltd, Bangalore, India

Dec 2008 to Jan 2012

Associate Manager - GxP Quality Manager

Sep 2011 to Jan 2012

Team Lead - GxP Quality Manager

Oct 2010 to Sep 2011

- Responsible for GxP compliance and Quality Management in SAP projects for

an UK based Pharma Company.

- Experience in QA Methodologies, creation of SOPs, reviewing and approving

Test Plans, test scripts and Test procedures, Traceability matrix, Design

Specifications, Change Controls for Pharma Supply Chain Management models

Regulatory Inspection Readiness Subject Matter Expert

Dec 2008 to Oct 2010

- As an offshore team lead, provided subject matter expertise, Project

management and Operations management for the Global Study File Management

and Inspection readiness team, Wyeth Pharmaceuticals

- Responsible for people Management, including goal setting and providing

performance feedback

- Successfully led a 10 member Inspection readiness team, steering quality

reviews of documents and Trial Master File readiness to withstand

potential inspections by regulatory agencies

- Responsible for Technical problem solving including understanding of US

and International regulatory agencies MHRA, EMEA, PMDA for Trial Master

File Management across multiple therapeutic areas (Oncology, Hematology,

GI, Neuroscience and Vaccines).

- As a client liaison, responsible for Knowledge transfer and ensuring

optimal customer satisfaction with successful management of Service Level

Agreements

- Assessed gaps and risk analysis, provided improvement strategies in areas

of concern

- Worked closely with the client Global Study File Management team to

promote efficiency and consistency in remediating issues with vendors and

investigator sites

CLINTEC (India) International Pvt. Ltd, Bangalore, India

July 2006 to Nov 2008

Senior Quality Assurance Executive

- Designed and implemented the Quality Management System including SOP

development, CAPA program, Gap analysis and risk assessment under the

supervision of the Quality Assurance Director

- Performed a comprehensive range of Investigator site audits, System

audits and Vendor qualification audits for Phase II, Phase III and

Bioavailability and Bioequivalence studies

Therapeutic areas include - Oncology and Respiratory disease

- Performed quality review of regulatory documents (protocols, amendments,

eCTD summary documents, appendices and clinical trial disclosures) to

ensure compliance with style guides, regulatory guidelines and publishing

requirements

- Conducted GCP training for Pharma companies and CROs

Quintiles India Pvt. Ltd. Bangalore, India

Aug 2004 - July 2006

Senior Clinical Research Associate

Two years of clinical research monitoring and clinical operations

experience (including clinical trial start up activities, feasibility

studies, site selection, initiation and routine monitoring) in Phase II and

Phase III global studies.

Therapeutic areas include -Psychiatry and Vaccine studies

RELEVANT TRAINING:

- Dec 2010 - Sponsor training on GxP Quality Management system, Overview

of SAP and Integration Services, Manchester, UK

- Apr, May 2009 - Sponsor training on Regulatory compliance, Study file

management functions and Inspection readiness, Cambridge and

Collegeville, USA

- 14 Mar 2007- 28 Mar 2007- Quality Management Systems and compliance,

ClinTec International, Windsor, UK

- 12 Mar 2007- 14 Mar 2007 - GCP auditing- Principles and Practice-

Cambridge, UK - British Association of Research Quality Assurance

- 5 Apr 2007- BA/BE Auditing, Pinnacle Health Care, Mumbai, India

- Dec 2006 - Clinical Trial Auditing 2006- GCP regulations and

Guidelines and GCP audits, Data Management audits and for cause and

Fraud detection auditing. Pinnacle Health Care, Mumbai, India

CONCEPTUAL TRAINING:

Project Management and Operations training include: Six Sigma Green Belt,

Advanced Leadership & Professional Development, Management to Leadership,

Operational Maturity Fundamentals, Quality Management, GAMP 5 Guidelines,

FDA standards (21 CFR Part 11),GCP regulations

2011- Life Sciences Industry Generalist Certification - Accenture, India

EDUCATION:

Date Qualification

Institution

2002- 2004 M. Sc Biotechnology

Bangalore University, India

1999-2002 B. Sc Microbiology

Bangalore University, India

SKILLS:

- Hands on experience in HP Quality Center

- Software - Microsoft Suite

- Basic understanding of Software Development Life Cycle

- Programming languages and Operating systems include - C, C++, UNIX

AWARDS:

2011: Accenture India Life Sciences Best Presenter Award

2009: Accenture Alchemist Award for exemplary contribution made towards

People Development

2009: Accenture Whiz kid Award for innovation and process improvements

2005: Achievement award recognizing the efforts during the trial start up

for the Organon study

2005: Achievement award for the dedication and commitment for the

AstraZeneca psychiatry study

2005: Achievement award for the AstraZeneca Psychiatry study

ADDITIONAL INFORMATION:

U.S Permanent Resident

Contact this candidate