Project Information Management
Resume:
Hemin Shah MS
(C) 607-***-**** *** Lower State Road, North Wales, PA 19454 @: ************@*****.***
Validation Specialist
Professional Summary
More than 4 years Hands-on experience in cGMP with Master’s degree in pharmaceutical manufacturing
Gained expertise in Validation followed by current corporate System Development Life Cycle (SDLC)
Faced exceptional opportunity in Consent Decree environment to resolve complex compliance issues
Current Knowledge of CFR Part 11, cGMP, GLP, EU Annex 11, ICH and global Health Authority Regulations
Skilled in equipment validation of HPLC, Particle counter, Autoclave, Coating equipment and Spectroscopy.
Hands-on experience with compendial testing concerning USP (United States Pharmacopeia) and EP
Efficient and Productive in pharmaceutical test techniques like GC, HPLC, Spectroscopy and Wet Chemistry
Proficient in Empower3 Feature Release 2, QUMAS,HPQC,ALM,QTP, MS Project, MS office, MS Word, MS
Excel, Visio and SAP
Cleaning validation, CFR Part 11,(CSV) Computer System validation, (LIMS)Laboratory information
Management system, Quality Control, Project management, Qualification, Validation, (cGMP) Current Good
Manufacturing Practices, (GLP)Good Laboratory Practices, (CDS) Chromatography Data System,
ICH(International Conference on Harmonization)
Equipment/System Expertise
Beckman Coulter Particle counter Empower 3 feature release 2 CDS
Agilent HPLC QUMAS/SAP
Waters HPLC/UPLC/ UV Vis Spectroscopy Catalyst Labe ware LIMS
Auto Clave/ Atomic absorption Spectroscopy Open Lab
HPQC/ALM/QTP SDLC
Professional Experience
Covex LLC- McNeil Consumer Health Care (J&J Family Company) Dec-2014 to Current
Validation Specialist
• Assisted in new J&J multi-site evaluation for Empower3 deployment and release.
• Authored validation documentation like URS, TDS, UAT, Retirement plan, Migration plan and Summary.
• Authored and Executed test script HPQC, ALM or QTP for validation activities.
• Successfully created and executed latency testing scripts for new site inclusion.
• Responsible for master data qualification process execution, IQ OQ test protocol development.
• Serving as master data mentor and point of contact for any queries regarding master data life cycle.
• Applying Corporate SDLC (System Development Life Cycle) principles to multi-site deliverables.
Covex LLC -Merck West Point Oct-2014 to Dec-2014
Validation Specialist
• Responsible for Qualification (SDLC) for particle counter in R&D Lab.
• Executed test scripts, validation package, validation summary and
• Developed validation plan, Requirement specification, Configuration specification, Requirement Traceability Matrix, IQ,
OQ, PQ and Validation summary Report
Covex LLC- McNeil Consumer Healthcare-Fort Washington (J&J Family Company)
QA Scientist-I June-2014 to Oct-2014
• Streamlined Empower 3 transition from Empower 2 by providing extensive support to QC team
• Performed qualification for HPLC, UPLC system with Empower 3 CDS in laboratory.
• Excelled Empower 3 Software Report and Processing Method Qualification in QC Lab
• Excelled Empower Software Integration seamlessly in to Quality Control Department
• Developed Empower 3 Custom Report, Processing Method Test Case and Technical Design Specification
• Drafted Change Control document to initiate the Empower 3 Cutover instrument connectivity
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Norwich Pharmaceuticals- Norwich, NY
Quality Control Chemist Sep- 2011 to May-2014
• Analyzed Stability, Release, Process Validation and Cleaning Validation Samples
• Excelled Empower Software Integration seamlessly in to Quality Control Department
• Participated in Catalyst LIMS (Laboratory Information Management System) integration
• Developed Controlled method template, Calculation Spreadsheet and Empower Calculation Report
• Carried out Investigation of Out of Specification and Out of Trend results to finding root cause
• Solved instrumentation problems and troubles to ensure lab quality procedures were followed
• Conducted calibration of the laboratory equipment, Reagent Preparation and log book entry
• Performed Quantitative analysis using HPLC, GC, UV, IR Spectroscopy and Wet Chemistry Techniques
• Remained current with and complied fully with cGMP, SOPs and Test Procedures to avoid OOS
EDUCATION
Stevens Institute of Technology, NJ GPA 3.40/4.00
Master of Science in Pharmaceutical Manufacturing Practices 01/2008-12/2009
Rajiv Gandhi University of Health Sciences, INDIA GPA 3.40/4.00
Bachelor of Science in Pharmacy 12/2002-09/2006
Educational Project Work
• Validation package -programmable coating equipment (Validation master plan, User Requirement Specification,
Functional Specification, Installation Qualification, Operational Qualification, validation Summary)
• Master Project Plan for upgrading existing aseptic vial filling facility (Includes project management tools and
pharmaceutical regulatory requirement)
• Redesign of current facility according to GMP requirements. (HVAC, Room Classification, Gowning requirements,
Air locks, Space allocation, material flow, people flow, equipment flow and air flow)
GRADUATE CERTIFICATE
Stevens Institute of technology, Hoboken, NJ 2010-MAY
• Bioprocess Systems in Pharm. Mfg. (BSPM)-Biotechnology processes, specific Bio-pharm facilities
design concept, issues, and sterile facilities approaches
• Project Engineering in Pharm. Mfg. (PEPM)-Project management concepts, specific implementation
concepts for sterile facilities, and the newer PAT (Process Analytical Technology) concepts
• Pharmaceutical Manufacturing Practices (PMP)-Concept all manufacturing processes, facilities design
issues, validation and regulatory affairs concepts which drive the pharmaceutical industry
PROFESSIONAL ASSOCIATIONS
• American Society for Quality Philadelphia (ASQ)
• (ISPE )International Society of Pharmaceutical Engineers
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