Quality Assurance Project
Resume:
SHRADDHA S MORE
REGULATORY AFFAIRS/ QUALITY ASSURANCE SPECIALIST
********@*****.***
Gaithersburg, MD 20878
PROFESIONAL SUMMARY
• Over 5 years of experience as Regulatory Affairs / Quality Assurance Specialist in
developing and implementing regulatory strategies for Pharmaceutical and Medical
Devices manufacturers.
• Experience of USFDA compliance of 21 CFR Part 11, 58, 210, 211, 812, 814 and 820 and
QSR, cGMP, GLP standards, ICH and IRB guidelines and GCP requirements.
• Experience with international regulatory submissions and registrations for EU, China,
Canada, Japan, Australia and Korea. Well versed with technical dossiers, STED, MDD
2001/83/EC, AIMDD 90/385/EEC, IVDD 98/79/EC and regulatory laws in these countries.
• Extensive experience on medical device domestic and global registrations. Expertise in
regulatory submissions like Premarket notification (510 k), Premarket Approval (PMA),
Investigational Device Exemption (IDE), Humanitarian Use Device (HUD) application,
amendments, supplements, Certificate for Foreign Government (CFG), Certificate of
Free Sale (CFS), Declaration of Conformity (DoC), license and facility registration
renewals.
• Thorough understanding and expertise of pharmaceutical business including R&D, clinical
and regulatory submission processes such as New Drug Application ( NDA), Biologic
License Application (BLA), Abbreviated New Drug Application (NDA), and
Investigational New Drug Application (IND), Drug Master File (DMF) Dossiers, annual
reports and supplements in paper as well as eCTD format.
• Expertise on internal FDA regulatory review processes such as 21st Century Review
Process, PDUFA and GDUFA goal metrics, and FDA legacy databases DARRTS,
Panorama, FAERS, etc.
• Expertise in Pharmacovigilance and drug safety technologies such as FAERS ( FDA
Adverse Event Reporting System), Argus Version 6 and 7, ArisG, MedWatch 3500A,
CIOMS I, ICSRs, ICH E2B, Triaging and data processing.
• Expertise in on platforms like Quality Management System (QMS), ISO 9001, ISO 13485,
Change Control Process, Statistical Process Control (SPC), Lean Six Sigma and
Electronic Data Management System (EDMS).
• Worked on Software Development Life Cycle (SDLC), familiar with Waterfall and Agile
Model.
• Experience in developing and reviewing Business/User Requirement Specifications (URS),
Requirements Traceability Metrics (RTM), and Design Specifications (DS).
• Extensive experience in developing, reviewing and executing Test Plans, Test Cases, Test
Scripts, User Acceptance Test Protocol (UAT) documentation.
• Worked on automated testing tools like HP Quality Center, Toad and JIRA and reporting
tools like Business Objects XIR3, OBIEE, and Informatica.
• Expertise in Documentum and SharePoint.
Excellent communication, analytical, interpersonal and presentation skills; expert at
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managing multiple projects and building strong relationships with diverse clientele.
TECHNICAL SKILLS:
Regulatory submissions and INDs, NDAs, ANDAs, HUDs, IDEs, PMAs, 510k s, supplements,
annual reports, UDI, labeling, CFG, CFS, SAEs, MDR & FCA
tools
reports. eCTD Publisher, eSubmitter, SharePoint, Documentum,
Trackwise.
Quality Management System Drug Master Files (DMF Type II and Type IV), cGMP, GLP,
GCP,CMC, Batch records, Design History Files (DHFs), Standard
documentation
Operating Procedures (SOPs), Travelers, Validation and verification
test cases and test reports.
Technical Writing User Requirement Specifications (URS), Design Specifications (DS),
Requirement Traceability Matrix (RTM), RUP Analysis model, Test
Plans, Test Cases, Test Summary Reports, User Acceptance Testing
(UAT) documentation.
Testing Tools HP Quality Center, Toad, JIRA, and Load Runner
Application Softwares Oracle AERS, Argus, Aris G, SharePoint and Documentum.
MS Office Suite MS Word, MS Excel, MS Access and MS PowerPoint, MS Project
Plan, MS Visio.
Programming Languages HTML, XML Data base query language SQL.
Databases FDA DARRTS, FDA Panorama, FDA AERS, Toad, SQL Server and
Oracle 11g.
Operating Systems Windows 95/98/2003/2010/XP/VISTA
Wet Lab Skills Molecular biology: Maxi and Mini prep of rDNA, PCR, Western
blotting, Macromolecules& enzymology: SDS PAGE, Ion exchange
chromatography, and HPLC Immunology: RIA and ELISA.
WORK HISTORY:
Client: Food and Drug Administration (FDA)
Regulatory Business Analyst/ QA Tester
Dec 2013 – Till Date
The FDA Mercado project involves understanding and executing the business requirements of the
client in context to analyzing and publishing different review processes and user reports. The
project’s work primarily focuses on working with client (FDA CDER) in developing; testing and
deploying reports based on 21st Century Regulatory Reviews and Adverse Event Reports received
by the agency.
Responsibilities:
• Interface with FDA Mercado users (Regulatory project Managers and Implementation
Managers) and Deloitte technical team to develop and document high level reporting
requirements documents for Mercado Dashboards based on agency’s 21st century
regulatory review process for INDs, NDAs, ANDAs and BLAs, Adverse Events data,
PDUFA and GDUFA goal metrics. Work with implementation teams to test and demo
analytic reports based on FDA’s Document Archiving, Reporting, and Regulatory Tracking
System (DARRTS), Tracked Safety Issue (TSI), and FDA Adverse Event Reporting System
(FAERS) databases. Also work with CDRH in streamlining internal regulatory systems for
MDR reporting and Facility Registrations.
• Support the team as an Adverse Event Subject Matter Expert as per project’s
requirements. Help understand client’s processes such as regulatory submissions and
approvals, adverse event reporting and related databases.
• Create C&S and functional test cases for validating consistency, aesthetics & quality of
Mercado OBIEE/data analytics reports that are published to users. Document test results
and update files SharePoint and JIRA.
• Develop and document data validation scenarios to verify that dashboard display accurate
information and calculated fields specified in requirements. Build & execute SQL queries
to validate data against the data warehouse Documents test results in HP quality center and
JIRA.
• Develop and update CMMI (Capability Maturity Model Integration) level 3 documents
such as project plans, requirements and testing plans, communication plan, and
configuration management plan.
• Gather and develop HHS Enterprise Performance Life Cycle (EPLC) Business Process and
Software Development Life Cycle (SDLC) Business Process documents as required by
management. Coordinate with Mercado project leads to compile high level tasks, project
milestones, timeline, dependencies and resources in Microsoft Project Planning tool.
Client: Bausch and Lomb, Surgical Headquarters
Regulatory Associate
Jun 2013 – Dec 2013
The global regulatory headquarter is involved in filing and maintaining worldwide regulatory
electronic submissions for all medical devices developed and manufactured by the client. The team
of interns and specialists reported to the Directors of global and US regions.
Responsibilities:
Assisted in obtaining and renewing global regulatory registrations/licenses in countries like
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China, Japan, Korea, New Zealand and Canada for Class II and Class III devices used in
eye surgery.
Participated in developing and submitting 510k submissions for sterilized and reusable
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surgical tools under supervision of the Associate Director. Developed and reviewed
substantial sections like executive summary, non clinical testing, sterility testing and
discussion of substantial equivalence.
Performed analysis of impact on regulatory status and dossiers for product changes of
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Class II and Class III products. Developed and submitted certifications such as CFG, CFS
and DoC for international registrations.
Developed and updated labeling and advertising material per regulatory requirements for
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existing and upcoming product lines.
Assisted in submitting initial regulatory submissions including new clinical data for Class
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III devices to Health Canada.
Assisted in developing and updating protocols and reports on Recall strategies, Risk
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Analysis procedures and relevant records in Documentum and Catsweb.
Trained in Adobe PDF editor, SharePoint, Documentum and Catsweb databases, Filing
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systems.
Participated in a two day LGA annual audit as a backroom supporter.
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Client: University of Southern California
Regulatory Business/ QA Specialist
Apr 2012 to May 2013
The goal of this project was to develop, design and market unique medical devices for infant and
adolescent population. The project involved gathering user requirements, developing and executing
design specifications and performing verification and validation testing on prototypes and
processes for fetal pacemaker, pediatric infusion pump, IVD strips and glucometer. The
multidisciplinary project team involved cardiac surgeons, biomedical engineers and regulatory
personnel.
Responsibilities:
• Lead a team of six biomedical engineers for two start up companies, to develop and
document QMS processes compliant to 21 CFR 812, 814, 820, ISO 13485, and EU
directives and standards.
• Developed and received successful approval on two HUD submissions for Class III medical
devices such as fetal pacemaker and pediatric infusion pump.
• Developed sections of regulatory submissions like HDE, PMA and 510 k for CDRH and
SFDA approvals.
• Gathered User Requirements to develop the design specifications for the prototypes and
manufacturing processes. Performed technical and design reviews for accessing impact
of design changes on manufacturing process and safety of the devices.
• Trained team of engineers to develop and implement SOPs, Protocols, Reports, Travelers
and Assembly flow charts, Incoming and in process inspection documentation for
GMP and GLP compliance per 21CFR 820 and ISO 13485.
• Developed and implemented procedures for Design History File ( DHF), Device Master
Record (DMR), Device History Record (DHR), Bill of Materials (BOM) for class II and
class III medical devices.
• Performed Risk analysis of the product and processes compliant to ISO 14791 using FTA,
FMEA, Lean six sigma tools and methods. Established complaint handling system for
MDR reporting.
• Participated in developing IACUC protocol and IRB clinical trial protocols, start up
clinical trial framework and documentation.
• Developed systems for pre and postmarketing vigilance (CAPA assessment and MDR
reporting), labeling verification and updates.
Evaluated and developed system for labeling, package inserts, and UDI compliance and
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established change control process for product/process changes.
Client: Pfizer
Regulatory/Safety Analyst
Aug 2010 – Dec 2011
The training and successive assignments with various clients involved understanding and executing
the concepts of pharmacovigilance and drug safety techniques. The projects involved extracting
medical data per the requirements of various drug safety databases.
Responsibilities:
• Extracted relevant medical data into standard case template and review adverse event cases
reported during clinical trial investigations (INDs) and performed triaging based on
MedDRA coding.
• Generated well written, concise and accurate Case Narratives for both serious and non
serious cases. Reconcile Serious Adverse Events (SAEs) reported in pre and post marketing
studies.
• Utilized the functionality and features of Oracle Argus Safety Database (Version 6 and 7)
and Aris G Database to enter data in client database system.
• Accessed and utilized sources such as FAERS (FDA Adverse Event Reporting System),
MedWatch 3500A and 3500B, CIOMS I, PSURS, SUSARS and ICH E2B Guidelines.
M J Biopharmaceuticals
June 2009 – June 2010
Regulatory/QA Associate
Responsibilities:
Assisted local regulatory team in developing and maintaining regulatory submissions for drugs
and biologics developed by the company. Assisted Quality Assurance team in developing and
maintaining required regulatory documentation, for given product lines.
• Assisted in regulatory submissions (BLAs and Annual reports) of antidiabetic
drugs (Humanized Insulin) for DCGI, CDER and CBER.
• Assisted in developing and submitting IND, ANDA and Annual Report
submissions for antibiotic drugs (Cephalosporin injectable) in paper and electronic
CTD format. Actively worked on CTD Module 2 (ISE and ISS summaries), Module 3
(Quality) and Module 5.
• Assisted in using Liquent In Sight Publisher platform (RIM) and eSubmitter for
document preparation, legacy conversion, scanning, rendering, bookmarking,
hyperlinking, compilation, table of contents creation, volumation, pagination, and
formatting of large submissions, compliant to 21 CFR 11.
• Worked on template conversion and word document formatting
using Liquent SmartDesk into acrobat versions.
Assisted in developing and maintaining Drug Master Files and Biological
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Bulk Master Files (BB MF) of above mentioned products.
EDUCATION & CERTIFCATIONS:
• Master of Science, Regulatory Science, University of Southern California
(Jan 2012 – May 2013; cGPA: 3.81/4)
• Master of Science, Pharmacy, NIPER Ahmedabad
(Jun 2007 – June 2009; cGPA: 3.94/4)
• Bachelors of Science, Pharmacy, University of Pune
(Jun 2004 – Jun 2007; cGPA: 3.96/4)
• National Gold Medal for highest cGPA for Master of Science, Pharmacy (2007 2009)
• Certification of attendance and participation at The 15th Annual FDA OCRA Conference (2012
2013)
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