Management Customer Service

Mauna Patel

Bridgewater, NJ *****

*******@*****.*** ? 908-***-****

DISTINCTION

AWARDS

ConvaTec, Inc

. 2009: Information Management Distinction Award for Outstanding

Contribution

. 2008: Award of Distinction for Leading Strategically & Collaboration

PROFESSIONAL

EXPERIENCE

Advanced Clinical (Contractor)

Princeton, NJ

PV Compliance and Training Specialist (March 2014 - February 2014)

. Monitor, investigate and assess corrective/preventive action reports

(CAPAs) for individual case safety report (ICSR)

distribution/submissions in accordance with Otsuka processes,

reviewing for consistency and accuracy.

. Management of review and approval CAPAs in Trackwise

. Liaise with Otsuka departments/teams internal and external CS&PV to

address and respond to CAPAs from internal quality audits and support

regulatory inspections as needed.

. Provide Project Management support with tracking of detailed timelines

and progress of all deliverables associated with CAPAs

. Assist and coordinate global safety audit/inspection activities.

. Evaluate global safety reporting processes and metrics, perform

trending and identify areas for process improvement.

. Compile monthly metrics report for senior management on global ICSR

compliance and drug safety aggregate reports submissions.

. Manage monthly data updates to Pharmacovigilance System Master File

(PSMF) via close interaction with Regulatory, Aggregate and Safety

Management team.

. Provide Health Authority Request update submitted by Safety Management

team on monthly metrics.

. Compile metrics report for senior management on global compliance

. Review SOPs and provide comments from a quality management

perspective, representing pharmacovigilance.

. Perform quality reviews of training documentation to ensure compliance

with Otsuka processes for good documentation practices (GDP).

. Provide input on revisions to controlled documents/training

requirements, and identify new documents and training.

. Assist with creation of training material and documentations for

Regulated Inspection Readiness (IR).

. Assist with executing the UAT scripts for SuccessFactor learning

management system (LMS) to achieve project milestones.

ConvaTec, Inc

Skillman, NJ

Senior Change Management (July 2013 - January 2014)

Senior Change Control Specialist (Jun 2008 - July 2010)

Change Control Specialist (Apr 2006 - Jun 2008)

. Achieved Award of Distinction for Leading Strategically &

Collaboration for contributions to the Legal Name Change transition

(from Bristol Myers Squibb to ConvaTec); trained and supervised

temporary resources, provided project oversight, and upheld company

timeline objectives

. Achieved Information Management Distinction Award for Outstanding

Contribution for successful establishment of electronic document

platform and integration of legacy BMS

. Recognized for establishment of the Control Room Management team for

FDA inspections and Becker Audit by Senior VP of Global Quality

Management

. Authored UAT scripts for document change management routing and

approval system; coordinated UAT script execution to achieve project

milestones

. Developed modules and effectively trained 170 global users on business

and Electronic Document Management Systems (EDMS) on-site and via web

meeting/interactive sessions within a stringent 4-month timeline

. Work closely with Global team on updating training materials and

making them available for training in eLearning

. Run change request status reports on monthly to provide to management

numbers of reoccurring pending items

. Drove system improvements through application of quality principles,

practices, and procedural knowledge

. Lead continuous system improvement initiatives designed to meet or

exceed internal requirements

. Performed gap analysis based on audit findings and implemented quality

system improvements to reduce risk

. Collaborated with Engineering, Quality, and Operations to implement

improvements and proactively manage and mitigate risk

. Managed the Change Control EDMS Upgrade to ensure the integration is

seamless and there's no impact to system users or document workflows

. Managed development of modules for system upgrade and insure 500+

global users are trained on business and EDMS via eLearning within a

stringent 2 week timeline

. Reduced rejection rates and approval process cycle time through

improved consistency and compliance to company processes and document

controls

. Managed paper-based and EDMS global archival

. Demonstrated proficiency in SAP navigation when managing design and

manufacturing specifications

. Reduced costs and resource demands through effective management of the

Global Label Change Control process; ensured evaluation of change

impact by regulatory and marketing departments and successful label

transfer

. Established and monitored global quality system metrics; identified

opportunities to benefit financially and presented reports to senior

management

. Upheld company-wide quality standards by establishing and maintaining

change control principles and processes at manufacturing sites

. Implemented on-site training across multi-functional groups in less

than two weeks at newly established Dominican Republic manufacturing

site

. Demonstrated in-depth knowledge of 21CFR Part 820 and, ISO 9001:2001,

ISO 9001 and ISO 134485 Quality System Standards through translation

and application of Change Controls and Document Controls

. Performed root cause analysis in order to develop and implement

effective CAPA working with cross functional teams

. Audit Global sites to ensure execution of Change Control for

compliance to business and system processes

. Proactively identified areas of opportunity with the World Wide Change

Control process and provides reasoned solutions for improvement

. Managed worldwide project changes that affect multiple sites and

specifications to ensure business and system compliance

. Communicated with diverse team (R&D, Engineering etc) and functions to

foster efficient processes, continuous improvement and integration

across the organization

Dr. Reddy's Laboratories, Inc.

Bridgewater, NJ

Sr. Associate Quality Assurance (April 2011 - July 2013)

. Interfaced between internal and external parties such as project

managers, packaging development and vendors during the projects to

meet deadlines. Managed QA database to ensure kick off by connecting

with project managers via project tracker.

. Supported OTC Business: Reviewed, approved, and distributed

controlled packaging components, labeling, and related specifications.

. Provided final QA approval and archival of the packaging component

matrix, color standards, tail gate samples to align with Dr. Reddy's

and FDA Requirements. Managed QA approval of bill of material

change.

. Change Control Management (CCM): managed quality notifications through

SAP in terms of reviewing, routing, following-up and closure of change

controls.

. Quality Management System (QMS): managed distribution/issuance and

archival of hard copies and approved database for the Standard

Operating Procedures (SOPs). Created, reviewed, controlled and

implemented SOP related to North America Generic's Quality System.

. Management of external parties' documentation and SOP related to

product packaging, holding and distribution by connecting with

vendor's QA department.

. Interacted with IT team globally to assist in SAP improvement and roll-

out for Quality Notifications Management System.

. Shaped tracking of employee training by creation of Access database

for gap analysis as per existing training curriculum.

. Managed creation and maintenance of Quality Management metrics for

tracking and trending of quality events.

. Managed re-work project of Rx product within short period of time to

help with smooth launch at the distribution center.

. Expedited review during OTC product launches thus contributing towards

early achievement of $100 million for OTC business unit.

. Re-designed secure Document Control Room for systematic archival and

easy retrieval.

. Actively supported CAPA process to drive improvements.

. Managed the CAPA process: investigation, completion and

effective implementation.

. Contributed during the regulatory inspections by providing necessary

documentation and assistance.

Integra Life Sciences

Plainsboro, NJ

Corporate Quality Systems Document Management Specialist (October 2010 -

March 2011)

. Implemented and controlled the Corporate Document Management System

(CDMS) as both a paper system and electronic read-only system visible

on the terminal server for all Integra Life Sciences facilities.

. Processed and maintained Corporate Label Review and Approval Process

for all Integra facilities for the purpose of tracking the process and

minimizing the timeframe for approval(s).

. Tracked and initiated all promotional material for the Corporate

Office for English Language documents.

. Administrated and updated Corp. Quality Systems and Document Control

SharePoint websites.

. Co- Lead the rollout of the Promotional Material Process from a paper

based system to an electronic document system.

. Managed and implemented a global training rollout plan; Train users

globally on Quality Systems and on the CDMS & QA Systems

. Assisted with authoring project documentation and with system design

of the Promotional Material system

. Lead to develop processes to ensure archival of regulatory documents

in a central repository and required access and distribution as needed

. Reviewed and approved all labeling, advertising, and marketing

materials for the company's products; managed cross-functional review

through the Promotional Material Process

. Assisted Marketing group in developing Marketing Labeling and

Promotional Material

. Ensured that agreed-upon marketing and promotional material concepts

are efficiently implemented and that strategies are maintained in-line

with changing regulatory needs and business needs.

. Coordinated and controlled division PMAP process and approval matrix

. Coordinated review and revision of procedures, specifications, labels,

validation protocols and validation reports. Files are maintained on a

controlled system, in addition to hard copy files.

. Coordinated the establishment of site QA metrics to support both

division and corporate requirements.

. Ensured dependable and timely results from Quality Control, including

Process Control and support for process changes in compliance with

GLP, QSR, and ISO requirements.

. Interacted and coordinated activities with other departments, external

vendors and customers.

Johnson & Johnson

Skillman, NJ

Data Systems Administrator / Analyst (Sep 2005 - Apr 2006)

Research Lab Coordinator (Jun 2004 - Jun 2005)

. Responsible for the daily creation and input of customer master data

to support the US Consumer Sector Order Management System

. Supported master data validation and governance modeling activities

. Supported the data specialists for pricing and promotional requests,

and maintained Customer, Product, Price, and Promotion Master Files

. Maintained Customer/EDI relationship data and daily audit logs for SOX

compliance

. Collaborated with the Customer Service organization through customer

master activities to satisfy order processing requirements

. Maintained Supplemental Fund maintenance and served as liaison between

Customer Service, Sales, Marketing, and Finance

. Provided On-Site Training for New Hire (Purchasing System), Global

Specification System, Safety Orientation, Records Management,

Documentum, and Calibration System

. Created and maintained Scientific Reports using MS Excel and MS Access

. Prepared presentations regarding budgets, new products, lab materials,

and research

. Consolidated data and technical reports for product launch

AVAYA

Basking Ridge, NJ

Communications Software Application Developer/Analyst (Feb 2004 - Jun 2004)

. Assisted in responding to customer and/or business requests for

reports and/or analysis from a database (eg. SAP-HR/Business Objects)

. Created and maintained a database to increase data retrieval

accessibility for various departments

. Demonstrated proficiency in Access and SAP systems through generation

of departmental reports and metrics

EDUCATION

Rutgers University / New Jersey Institution of Technology, Newark, NJ

May 2004

Bachelor of Arts in Information Systems

DeVry College of Technology, North Brunswick, NJ June

1999

Associate Degree in Computer Information Systems

SKILLS

Windows 2000/XP, MS Office 2007 & 2010 (Excellent in Word, Excel,

PowerPoint, Access, Project), Documentum (Database Management), SAP, LMS,

Argus, TrackWise, Publisher, Visio, Sharepoint, Adobe Acrobat,

Professional, Compliance Wire, SuccessFacctor, Ariba Buyer, EDMS, Lotus

Notes, Outlook, Snagit

Contact this candidate