Quality Assurance Project
Resume:
Chirag Shah
Woodbridge, NJ *****
**************@*****.***
SUMMARY OF QUALIFICATIONS
. Extensive experience in a regulated environment (FDA, EU, ICH, and
** *** Part 210,211, 11 (Electronic Records), 820, GAMP, EU GMP
Annex 11, and ISO standards 9001, 13485).
. 13 years of professional experience in cGMP, GTP, GLP, GXP and
Information Technology (IT) for Pharmaceutical, Biotech and
Medical Device environments.
. Project lead experience with computer system validation projects.
. Authored, reviewed and approved Computer System Validation and
System Development Life Cycle (SDLC) documentation including Risk
Assessments, Design Specifications, Validation Plans, User
Requirements Specification, Functional Requirement Specification,
Impact Assessment, User Acceptance Test(UAT), Test Scripts, System
Test Protocols (Installation Qualification/Operational
Qualification/Performance Qualification), Traceability Matrices,
and Summary Reports.
. Authored, reviewed and approved Computer System Validation
documentation for SAP, Trackwise, laboratory support systems
(LIMS), Document Management Systems, laboratory instruments,
Global Compliance Wire and Clinical Trial Data Management Systems.
. Experience with planning, development, validation, operational,
and retirement phase for computer and automated systems.
. Extensive experience in the areas of Quality Operations,
Validation, Corrective and Preventive Action (CAPA), Inspections, Auditing, Risk Management, Change Management, Clean
Room/Aseptic Environment, and Training Program.
. Experience in supervising consultants and technicians and overseen
Quality Assurance activities.
. Experience with Consent Decree Resolution projects. Develop
evidence binder for various Quality System Elements (QSE). Work
with FDA approved third party consultants to develop the Quality
System.
. Project Management experience in handling project life cycle
including design, vendor selection, audit, system testing,
commissioning, validation, operation, maintenance and as well as
meeting all project timelines and goals.
. Conducted Risk Analysis for several Quality Systems.
. Trained on ASTM-E2500 which covers the science and risk based
approach to verification of equipment and systems.
. Team player, project lead, problem solver and willing to travel.
EDUCATION
Stevens Institute of Technology, Hoboken, NJ
Master of Pharmaceutical Engineering
Graduation, Dec 2006
DDIT, Gujarat University, India
Bachelor of Science - Chemical Engineering,
Graduation, 2000
PROFESSIONAL EXPERIENCE
Computer System Validation Consultant (Consent Decree
Project) Sep 2012-Present
Johnson & Johnson, Fort Washington, PA
. Work as a project lead for computer system validation projects.
. Develop, review and approve standard operating procedures (SOPs)
for Computer System Validation life cycle.
. Prepare Computer System Validation documents for laboratory
support systems (LIMS) for trending Catalyst Report. Work with
Micro and Analytical lab to develop and implement the report.
. Validate spreadsheet for various departments.
. Working on to resolve the audit observations for Computer System
Validation Master Plan, Site Validation Master Plan, and Packaging
Validation Master Plan. Author the above validation plans.
. Prepare Traceability Matrix for various systems including mix
tanks, hold tanks, washer, and liquids compounding process and
automation validation.
. Verify the revised SOPs meet the Critical to Quality Attributes
(CTQs).
. Work with FDA approved third party consultants to develop the
Quality System.
Sr. Quality Assurance Associate (Validation)
Feb 2010 - Sep 2012
Aesculap Biologics (B.Braun Medical Inc. Company),
Breinigsville, PA
. Worked as project lead for computer system validation projects.
. Authored, reviewed and approved validation plans, test plans, User
Acceptance Testing (UAT), test scripts and traceability matrix for
Information Systems, especially for ERP systems (SAP).
. Authored, reviewed and approved Computer System Validation
documentation including Risk Assessments, Validation Plans, User
Requirements Specification, System Test Protocols (IQ/OQ/PQ),
Traceability Matrices, and Summary Reports for Laboratory
Equipment/Systems (Quality Control), PLC automation.
. Responsible for validating multiple systems such as SpectraMax
Microplate Reader, BacT/Alert, Endosafe, spreadsheet as per
company standards.
. Developed Project Plans and tracked project status.
. Demonstrated experience managing projects in a high volume
environment.
. Led cross-functional teams in order to complete several projects
on a very aggressive time line.
. Validated system according to quality standards, FDA Guidelines,
GxP and 21 CFR Part 11 Regulations.
. Maintained knowledge and expertise in compliance with various laws
and regulations (GxP, 21CFR Part11, GAMP5) and best practices.
. Developed standard operating procedures (SOPs) for Computer System
Validation.
. Possess thorough understanding of Computer Systems Validation
(CSV) concepts and testing practices in a GxP environment.
. Managed the change control process for Computer System Validation
projects.
. Provided training to Information System personnel and business
users on SOPs, and testing best practices in a GxP environment.
. Identified and developed new policies, procedures, work
instructions and other related documents for the Information
System department.
. Facilitated and hosted various meetings with business users,
Information System teams and the Change Control Board. Ensure each
change request has appropriate supporting documentation for all
assigned releases before the change is moved in the production
environment.
. Developed/Maintained Master Validation Plan for computer system
validation.
. Coordinated and provided technical support activities for the
Manufacturing, Quality Control and Facility departments.
. Developed, applied and revised Quality Standards documents
including SOPs, test methods, test procedures, work instructions,
audit reports and investigations in compliance to applicable laws
and standards.
. Participated in project meetings to ensure that current validation
best practices and compliance expectations are integrated into
written protocols by providing guidance on applicable regulations,
internal policies.
. Troubleshoot issues that arise during execution of validation
protocols by reviewing and approving root cause, deviation report,
recommending corrective/preventive action.
. Worked with Engineering, Manufacturing, and External Consultants
to ensure QA Validation compliance for process control systems and
computer system validation.
. Performed internal and external audits to GMP compliance, Quality
Standards, company policies and procedures.
. Capable of applying Quality Tools, such as FMEA (Failure Mode and
Effect Analysis), HACCP (Hazard Analysis and Critical Control
Point).
. Participated in third party and regulatory inspection activities.
. Supervise outside validation consultants and oversee computer
system validation activities.
. Assisted junior staff to provide coaching and guidance on
regulatory requirements for the validation activities.
Validation Specialist III
Mar 2007 - Feb 2010
Pfizer Inc. (formerly Wyeth Pharmaceuticals), Pearl River,
NY
. Worked as project lead for computer system validation projects.
. Worked with FDA approved third party consultants to develop the
Quality System.
. Overseen computer system validation activities.
. Reviewed and approved Computer System Validation documentation
including Risk Assessments, Validation Plans, User Requirements
Specification, System Test Protocols, Traceability Matrices, and
Summary Reports for process automation systems, process control
systems, ECS systems (Trackwise, SAP, Lab ware LIMS) and Quality
systems at Pearl River site.
. Reviewed and approved Software Development Life Cycle
documentation for Document Management System (Documentum)
implementation.
. Assisted in review of validation documents of MES (Manufacturing
Execution System) by (PMX Rockwell) for electronic batch records
at the site. This included interfacing SAP, LIMS, and CDAS
document management and automation systems together to complete
the batch record electronically.
. Developed standard operating procedures (SOPs) for Computer System
Validation.
. Completed CFR Part 11 assessments for various computer systems.
. Maintained knowledge and expertise in compliance with various laws
and regulations (GxP, 21CFR Part11, GAMP5) and best practices.
. Reviewed and approved Installation Qualification, Operational
Qualification and Performance Qualification Protocols including
autoclave, SIP/CIP skids, and automation validation.
. Reviewed and approved CSV Performance Qualification protocols for
Product Transfer Skid (PTS) to download Polysaccharide from final
fill tank to 250 L tank through sterile filtration and finally to
50L drums.
. Participated in project meetings to provide guidance on applicable
regulations and internal policies.
. Resolved issues that arise during validation executions by
reviewing and approving root cause, deviation report, recommending
corrective/preventive action.
. Performed internal and external audits to GMP/GTP compliance,
Quality Standards, company policies and procedures.
. Reviewed corrective actions to assess effectiveness of solutions.
. Worked with Technology, Engineering, Manufacturing, Information
Services and external consultants to ensure compliance for process
control systems, and quality systems.
. Reviewed and approved Quality Risk Assessment report for various
Quality Systems utilizing Quality Risk Management Tools such as
Failure Mode, Effects and Criticality Analysis (FMECA).
. Responsible for reviewing and approving Standard Operating
Procedures..
. Assisted junior staff to provide coaching and guidance on
regulatory requirements during Quality Assurance review.
. Adept at ensuring adherence to Quality Assurance standards, as
well as meeting all project timelines and goals.
Quality Assurance Specialist
April 2005 - March 2007
Taro Pharmaceuticals, Hawthorne, NY
. Reviewed and approved validation protocol final reports to ensure
protocols were properly executed and all deviations that occurred
during the execution phase were resolved satisfactorily.
. Monitored and tracked quality systems deviations and facilitated
the implementation of corrective and preventive action (CAPA).
. Conducted finished product and in-process release activities.
. Developed Supplier Qualification Program for new product.
. Performed Quality audits to ensure cGMP compliance of packaging
facility for contract manufacturers.
. Wrote and revised departmental Standard Operating Procedures for
material handling.
. Provided training for new employees.
. Applied to DEA for Import Declaration on continued basis, and
overseen inventory maintenance of controlled substances.
Validation Engineer
March 2004 -April 2005
Amneal Pharmaceuticals, Paterson, NJ
. Developed Process Validation and Cleaning Validation protocols for
solid dosage form equipment.
. Authored and executed validation protocols for cGMP equipment
including compression machine, blender, coater and utility systems
including WFI.
. Investigated and resolved issues that arise during execution of
validation protocols by writing deviation reports and recommending
corrective and preventive actions to be included in final reports.
. Performed periodic reviews of equipment and utilities validation
documents to ensure compliance with cGMPs and current regulatory
requirements.
QA Analyst Sep 2002 -
Feb 2004
Cimtech Inc, Iselin, NJ
. Worked on software development life cycle (SDLC) from user
requirements to design and implementation.
. Reviewed internal documentation for compliance with regulations
and industry guidelines. Handled external interactions related to
systems validation. Participated in internal, external and vendor
audits.
. Responsible for managing compliance with 21 CFR Part 11 for
assigned systems.
. Collaborated with other information technology groups on the
validation of internal systems infrastructure.
. Reviewed and approved Computer System Validation documentation
including Risk Assessments, Validation Plans, User Requirements
Specification, System Test Protocols, Traceability Matrices, and
Summary Reports for Global Compliance Wire and Clinical Trial Data
Management Systems.
. Lead and provided compliance guidelines on each phase of the SDLC
life cycle on the Corporate Adverse Event Reporting and Evaluation
System (CARES) infrastructure upgrade project along with
supporting few other systems such as EmBARC, TrecNET, Electronic
Data Management (eDM).
. Reviewed and approved System Tests, UAT, IQ/OQ tests in the HP
Quality Center.
. Responsible for adhering to defined specifications and meeting
project timelines.
Validation Specialist Nov 1999 -
March 2002
Luna Pharma, India
. Supervised validation technicians and overseen equipment,
facilities, and utilities validation activities.
. Authored, executed IQ/OQ/PQ protocols for various equipment
including blender, coater, autoclave, mixing vessel, and utilities
including WFI, Compressed air, Clean Steam.
. Authored, executed process validation protocols for blender,
coater, filling machine.
. Reviewed and approved lab instruments validation documents
including TOC analyzer, HPLC, and Gas Chromatography.
. Performed periodic reviews of equipment and utilities validation
documents to ensure compliance with cGMPs and current regulatory
requirements.
TECHNICAL SKILLS
Life Sciences: Project Management, Development/Implementation/
Validation, Qualification and Remediation of GxP systems
(cGMP/GLP/GCP), FDA Quality System Regulation, DQ/IQ/OQ/PQ/FDA
Compliance, cGMP/cGLP/cGCP/PDMA Audits, 21 CFR Part 11Assessements
and Remediation, Spreadsheet Validation, ERP, LIMS, Vision
Systems, PLCs, Levels 1-3 SOPs, Quality Assurance and Quality
Audit
Software: ERP (SAP), GxPharma, LIMS, Documentum, ISO train,
TrackWise, SCADA, Controls Systems, CAPA, SpectraMax Microplate
Reader, Kaye Validator 2000, Crystal Reports, Enterprise Document
Management System (EDMS), MES, Compliancewire, Maximo, MS Word,
Excel, PowerPoint, MS Access, C, C++, JAVA, BPCS (Business
Planning and Control System), WMS (Warehouse Management System).
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