Kamal R Shah

Linked in Id https://www.linkedin.com/in/kamal-shah-69860214

Parsippany, NJ 07054

973-***-**** adclxg@r.postjobfree.com

SUMMARY

•Technical Analysis,EHS Audit, PFDs, P&IDs, CAPA,KPI,Clinical Data Management,Clinical Trial.

•Updating SOP's and Control Specifications,TSCA,Best Practice, punch list, SAP database.

• Regulatory Compliance, QC/QA, Audits, cGMP,GLP,GCP,GDP,GxP,Document Change Management Process in CelDox, Veeva,Novastyle,NJ-EHS-Regulated Medical Waste

•Medical Device Risk Management per ISO 14971. Design Failure Mode and Effect Analysis (DFMEA)

•Good Documentation Practices Standard,Global Quality System Manual, Regulatory Inspection Readiness, Records Management, Identifying Data Integrity Deviations.

•Transfer of Analytical Test Methods, Biological Product Deviation Reporting (BPDR), Validation of Cell-Based Methods for Cell Therapy Development, Corporate Adverse Event Reporting Policy,Global Reproductive Health and Safety, Assay Control Standard Operating Procedure.

PROFESSIONAL EXPERIENCE

Bristol-Myers Squibb,Summit West,NJ Nov 2019 to Present

Technical Writer, QC Systems and Services

The Technical Writer,QC Systems and Services works independently and is responsible for the authoring of high-quality documentation in support of QC GMP testing at the CAR T manufacturing facility in Summit, NJ.

This includes,SOPs, work instructions, tutorials, methods, and specifications. authoring and revising GMP documents.

Ability to deliver high-quality documentation while paying attention to detail.

Quickly grasp complex technical concepts and make them easily understandable through text and pictures.

Familiarity with GMP electronic documentation systems.

Ability to work in a highly regulated environment and to follow Good Documentation Practices .

Advanced ability to work in a collaborative team environment and train others.

Ability to adapt to changing priorities and manage multiple assignments while meeting timelines.

Ability to set priorities for the group and mentor associates.

Strong organizational skills and critical thinking skills.Authors and revises GMP documents.

Authoring new documents to support GMP test execution including, but not limited to, equipment, training, sample management, and software.

Revising existing documents as needed.

Managing the development of documents through the electronic document management system.

Assisting in the execution of Change Controls as needed.

Working with internal teams to obtain an in-depth understanding of QC processes and their documentation requirements.

Producing high-quality documents that meet applicable standards and are appropriate for their intended audience.

Writing easy to understand instructions where required.

Creating tutorials to help end-users train on a variety of activities.

Creating and maintaining documentation projects and timelines.

Providing excellence attention to detail when writing or revising documents.

Applying critical thinking skills when developing documents for new procedures.

Celgene,Warren,NJ May 2019 to Nov 2019

Technical Writer

Authored non-validation protocols, Validation summary reports, and standard operating procedures and Validation parameter Analysis for Deviations in Veeva.

Worked closely with team to plan the startup readiness of CAR T cell manufacturing plant using SIPOC diagrams.

Writing and formatting Quality control documents like bulk gas handling, Sample management, Test methods and Specifications in Veeva.

Perform Calibration of MACSQuant Flow Cytometer.

Using Vaccum Aspirator for removing fluids from the wells without affecting cells.

Created cross functional flowcharts, Basic flowcharts and fishbone diagrams Visio.

Gathered requirements and Authored manufacturing documents pertaining to waste handling procedure in suites, movement of samples and reagents in process suites.

Worked closely with manufacturing and quality control team to perform root cause analysis for product specifications. Involved in making fishbone diagrams.

Authored and formatted standard operating procedures for equipment like particle analyzer, water purifier, cell processor, incubators, centrifuges, water baths in Veeva.

Gathered requirements and authored facility documents like contamination control, environmental monitoring for production areas in Veeva.

Authored and formatted validation summary reports for centrifuges, refrigerators, freezers, and incubators in Veeva.

Analysis for Validation parameterPrecision,Accuracy,Linearity,LOD/LOQ,Robustness,Stability.

Always access the source system during Health Authority Inspections,InternalAudits,Data Integrity Check,Data Governance.

Follow guidelines of CDER(Center for drug evaluation and research),MHRA(Medicines and health care products Regulatory Agency),FDA,EMA(European Medicine Agency),GVP(Good Pharmaco Vigilance practice)for European Union.

Responsible for IPV,Andotoxin,bb2121 Documents,Cell process Development(Assay Development),PBMC Flow Validation Protocol Supporting SOPs,CD3 Linearity Data Analysis,Linear Regression plot for T Cell Percentage.

Follow Good Practice for Data Management and Integrity in regulated GMP/GDP Enviornment.

Perform each run‘s QC Data package can be scanned and verified.

Perform Verification of scanning binders in Veeva to make REC effective.

Novartis,EastHanover,NJ Jan 2019 to May 2019

Technical Writer

To set up the governing documentation for the East Hanover Pilot Plant in Cell&Gene Therapy.

Knowledge of SDLC including system design, development and validation for regulatory requirements

Responsible for Standards and GXP,computer system validation (IQ/OQ,PQ), regulatory compliance 21 CFR Part 11, CFR 820, Part 1271,Part 211,29 CFR 1904,29CFR 1910,ISO 13485,14001,9000,9001 to meet the requirements of regulatory process as per IT-Pharma/Medical Device Quality and Compliance

Assists Analytical & Process Science on authoring developmental protocols and reports, as necessary.

Coordination of timelines, document revisions and review cycles for all GMP documents including delegation to the appropriate groups for review to ensure timely production start dates.

Manage validation projects within regulated environment, understanding of 21 CFR Part 11 guidelines, FDA GXP requirements and computer system validation documentation with Good Documentation Practice

Identify and anticipate risk of non-compliance and address them

Review of completed batch records and other GxP documents in collaboration with Quality Assurance as needed to ensure accuracy and completion in accordance with cGMP regulations.

Supports preparing Qualification Master Plans, Risk and Impact Assessments, Protocols and Summary Reports and coordinates review and approvals of the document

Authors/reviews/updates/assists in developing departmental standard operating procedures (SOPs) and qualification documents/programs.

Analyze QMS metrics and develop recommendations for improvement to the Management Team

Ensures that all activities are in compliance with cGMP, Health Authority regulations and the Client Policies.

Bellerophon Theraputics,North Brunswick,NJ Aug 2018- Jan 2019

Chemical Development & Laboratory Lead, Preclinical Regulatory Specialist

Member of Professional Team for commercial deployment of the iNO pulse Delivery System of current clinical trials

Knowledge of Lean Six Sigma, continuous process improvement throughout the enterprise

Possess experience working in pharmaceutical IT industry in a regulated IT environment with good understanding of complete drug life cycle process, ranging from drug discovery, clinical trials, manufacturing, to Pharma sales and marketing

Perform a broad set of laboratory activities, focused on the deployment of high quality, high reliability drug delivery system helps Medical Device Verification Activities,

Processing medical device return and servicing, including technical evaluations

Perform Medical Device Evaluation and verification technical activities

Work with Quality Management System software QT9(Automating your ISO requirements):ISO Compliance,ERP,Manufacturing Management Software, Integration Quality Integration, ASL 5000 Breathing Simulator, INGAR Medical Simulation Script Editor, Lab Chart Version 8 by AD Instruments, Service Control Module(SCM) revision 985

Responsible for Mark-2 Device Evaluation, calibration, compliance log, testing

Involved in Analysis of linear Regression of the flow volume and reporting of slope and intercept an error

Follow all FDA Guide line,Risk Management,Quality Management Sysytem,ContinuousImprovement,Regulatory Compliance

Becton Dickinson,FranklinLakes,NJ March 2017- June 2018

Research &Engineering

•Knowledge of Design control and working with Instron Tensile Tester with Blue hill 3.

•Perform Testing for Leakage past stopper to meet ISO7886:1,1993 AnnexD

•Reading and understanding Assembly drawings, manufacturing and test instructions, service manuals,

•Knowledge of all phases of SDLC/CSV lifecycle for enterprise system applications including Agile validation methodologies in Scrum environments and client specific methodologies

• Assist in product and prototype testing. Participate in Gage R&R studies.

•Document test results and communicate with R&D Engineers as required.Storng Technical Writing skills for Project and regulatory Documentation

•Provides feedback to Medication & Procedural Solutions (M&PS) Research & Development, Advanced Product Development Services (APDS)

•Play a critical role in supporting the group’s efforts with respect to medical device testing product for Design Verification and Shelf Life,Test Method Validation Summary Report

•Supports all product development and product engineering platforms across MPS, help the team by way of expertise and efficiency in a variety of mechanical, physical and electronic testing of medical device products, contribute to the improvement of existing testing methodologies, measurement system development & analysis of test methods, Competitive Analysis.

•Responsible for the testing performed will help ensure that products meet customer’s expectations and regulatory requirements(21 CFR Part 11), disciplined product development processes, regulatory, quality requirements and design controls, such as 21 CFR 820.30

•Test performed by following test protocol or test instruction written by Engineer & also Test consists cleaning a medical device using different disinfecting wipes will be used to evaluate and determine performance after completing the required disinfecting cleaning cycles.

• A functional verification will be performed connecting the device to established communication with software

•Knowledge on testing software, firmware and hardware by following test protocols

•Perform Mesurement system Analysis(MSA) for Different products and Testing

•Perform IQ(Installation Qualification),OQ(Operation Qualification),PQ(Performance Qualification) for infusion pumps and other medical device

Bureau Veritas,Linden,NJ Oct 2016- Feb 2017

Laboratory Inspections

•Operates laboratory equipment and instruments such as microscopes, centrifuge, agitators, viscometer, chemical balance scales, spectrophotometer, gas chromatograph, colorimeter, and other equipment.

•Maintaining a GMP and GLP Laboratory environment, including equipment maintenance and calibration management

• Test materials for presence and content of elements or substances such as hydrocarbons by ASTM methods.

•Proficiency in documenting results according to Good Documentation practice Standards

•Test samples of manufactured products to verify conformity to specifications and Records test results on standardized forms and writes test reports describing procedures use.

•Prepares graphs and charts and calibrates laboratory instruments

ExxonMobil,Clinton,NJ May 2015–Nov 2015

Research and Engineering

•Follow GHS of Classification and Labeling Chemicals,SDS and EHS Label creation, near misses.

•Coordinates and develops with Analytical & Process Science, Engineering and QA Teams qualification projects and plans and identifies the “critical to quality” parameters impacting qualification activities.

•Analytical skills to determine quality and reliability improvements based on laboratory Results .

•Responsible for Careful, deliberate, disciplined, meticulous, and well organized in performing Laboratory testing and recording results.

•As per OSHA Regulation updated data in Share Point for the new chemicals SDS,order shipment review and release,compliance with all federal, state and local regulations, implements policies and procedures, knowledge of EPA and DEA,Calibration of analytical instruments

•Perform testssuch as density, pour point, cloud point, and GC,HPLC,Sulfur, Viscosity, Flash Point, TDS,TSS, Conductivity, pH as per FDA regulation for QA,QC, GMP,R&Dand pilot plant programs

Qatar Petroleum,Qatar May 2009–Nov 2014

Operation Engineering

Familiarity with ASME, API, and NFPA, IDLH, SCBA, NIOSH, FEED,EPIC,FS,SOW,SOR,PCR, MCC, TOC,ACC, Fire, safety, ISO 9001, ISO 14001, confined space permit, Hot /Cold work permit

Driving the continual improvement of GMP Batch Records and SOPs between review cycle by soliciting and incorporating feedback from Analytical & Process Science, Engineering, and Quality groups.

Follow Standard Operating Procedures, Good Documentation Practices.

Used Maximo and continuous improve equipment preventative and corrective maintenance

SOR Evaluation, recommendation & final approval as a Focal Point

Participate for process related matters Reviewing PCR for approval / rejection and carrying out PCR detail engineering and making it ready for implementation.

Review & approve all permanent process & trip setting change requests to meet operation requirements, review & update documentation and drawing on periodical basis.

Successfully trained Qatari Trainee for the profile of senior process technician and provided them guidance and assistance

Reliance Industries Limited,India Aug 1989–May 2009

Process / Production/Manufacturing

Hazard identification &Risk Assessment before doing the job, strict control of unsafe conditionsand unsafe acts, Quality Management System, ISO Management, excellent understanding of LEAN and Six Sigma principles,EPIC,Project Management, scheduling and TA Planning, COS Removal

•Fall Protection, Provides Safety Hazard input to HAZOP, HAZIDstudies,excellent project coordination and execution skills, written PPE program and DOT regulations, Technical Writing.

•Creation and revision of GxP documentation including Production Batch Records, Standard Operating Procedures, and related documentation.

•Perform the job using appropriate Personal Protective Equipment, follows Standard Operation Procedures, Good Laboratories Practices and Good Documentation Practices.

Education:

Diploma in Computer Application— Sterlite Foundation (India), 2001

Bachelor of Science, Chemistry—Maharaja Sayajirao University (India), 1988

Volunteer: 20th World Petroleum Congress, COP18/CMP8 the UN Conference on Climate Change

Achievements: Received recognition for extinguishing a fire in the propylene plant at RIL, India

Software Skills:Bentley,Novastyle,Subway,FirstDoc TDMS, EDMS, ECM, SAP, LIMS, Matrikon,ASSAI,PDF Nitro, Lotus Notes, Microsoft Office, Lab View operating systems, Microsoft Visio, Adobe Acrobat,VeevaVault,E-Notebook,QUADS business analytics tool, CelDox,EQRMS Product Quality Complaints,EQRMS Deviations/CAPA,EQRMS,Global change Management,MicrosoftAccess,Sharepoint,APQR(Annual product Quarterly Review),GMR(Global Management Review), Office365,MACSQuantify™ Software

Training: Heart Saver First Aid CPR & AED, DIAMS,SHE level training, SHE critical equipment, LOTO, Oil spill prevention, OIMS, MOC, GHS, Web cat, safety in motion,, ISO 9001, ISO 14001, Cyber Security, Records Management, Data Privacy, GDP,Bloodborne pathogens, Risk Management,CelDox Editor/Owner,CelDox Next Gen Author Training Placeholder,NJ-EHS-Personal Protective Equipment,Veeva Vault Quality, Management and Usage of Logbooks,bb2121 End of Process Material Retention and Use Procedure, Promotion and Management of Promotional Materials,NJ-EHS-Decontamination of Laboratory and Process Equipment,Universal Waste and Used Oil, Laboratory Safety Manual, Facilities and Equipments, Hazardous Waste, Spill Response, Handling & Storage of Flammable Liquids, Incident Reporting And Investigation Program,QUADS General User Overview and Source System Load Status Header, GDPR Overview,Materials Management, Code of Business Conduct and Ethics,Data Protection and Privacy Policy, Corporate Supplier Sourcing Policy,LMS Modification Requests in CelService,Use of Electronic Laboratory Notebook (ELN) in Analytical Development and Technical Operations,Operation and Maintenance of Pipettes,Storage and Distribution Operations,General Calibration Program, Global Quality System Manual,True Copy Reinforcement Training,ComplianceWire - GMP Training Data.

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