Data Management System

Kamal R Shah

Parsippany, NJ *****

973-***-**** *************@*****.***

SUMMARY

•Technical analysis,EHS audit,PFDs,P&IDs,CAPA,KPI,clinical data management,clinical trial.

•Regulatory compliance,QC/QA,audits,cGMP,GLP,GCP,GDP,GxP,document change management process in CelDox,veeva,novastyle,NJ-EHS-regulated medical waste,PV,Updating SOP's and control specifications.

•Medical device risk management per ISO 14971/13485,design failure mode and effect analysis (DFMEA).

•Good documentation practices standard,global quality system manual, regulatory inspection readiness,records Management,identifying data integrity deviations,TSCA,best practice,punch list,SAP database.

•Transfer of analytical test methods,validation of cell-based methods for cell therapy development,corporate Adverse event reporting policy,global reproductive health and safety,assay control,standard operating Procedure,batch records review,TrackWise,QA lot disposition,MACSQuant flow cytometer.

PROFESSIONAL EXPERIENCE

Bristol-Myers Squibb,Summit West,NJ May 2019 to Jan 2024

Lead QA Compliance & Regulatory Affairs

Celgene,Warren,NJ

Lead QA Compliance,Analytical R&D

•Responsible for the processing of all training requests and successful maintenance of the training system current and accurate training curriculum(s) and assignments for GMP impacted areas.

•Provide technical support to the business as required for use of the learning management system.

•Provide training solutions to the site training program,GMP training,quality systems organization.

•Intermediate skills in design,development and implementation of training to navigate a document management system (DMS) and learning management system (LMS).

•Properly communicate e-mails and routine business matters with management with high level of accuracy, demonstrate basic writing skills and be able to follow technical reports.

•Excellent organizational,writtenskills,action-oriented,customer-focusedand possess learning agility, collaborates with internal ITto provide LMS troubleshooting,files all training documentation.

•Administers the electronic learning management and training management request system.

•Creates,assign and maintains GMP curricula and user groups for all supported functional areas.

•Provides reports,queries and metrics as requested from LMS for compliance and supports.

•Recognizes and resolves training discrepancies,communicates any such occurrence and corrective action to affected personnel,manages schedules and coordinates training for GMP courses.

•Reviews and approves accuracy of documents for training information and updates document effective dates through document management systems,uploads training scores as into LMS.

•Organizes,prepares and revise training course materials such as handouts,supplies and visual.

•Maintains curriculum catalog on all curricula data that is inputted into the LMS to ensure integrity.

•Authors documents regarding LMS processes,policies,trainings in DMS and resolve issues from internal customers related to the business and systems,completion of training system-related objectives..

•Trains new team members and one-on-one coaching to LMS learners,management or designee.

•Responsible for authoring and revising of high-quality GMP documentation in support of quality operations at the Summit cell therapy manufacturing facility,in accordance with celgene policies,standards,procedures and global cGMP includes,but not limited to,SOPs,work instructions,reports and technical documents.

•Support of dispositioning product for compliance with client directives,procedures and regulatory standards.

•Visit to the production floor and qualify the equipment in the laboratory prior to doing the validations.

•Responsible for quality expertise and oversight of the batch disposition process to deliver high-quality documentation as per FDA and ICH guidelines in highlight regulated environment and to follow GDPs.

•Ability to quickly grasp complex technical concepts and make them easily understandable through text.

•Strong knowledge of Microsoft Office,data graphics software,adobe acrobat and web-based browser software.

•Collaboratively work with manufacturing and cross-functional stakeholders to ensure deliverables are met to support disposition and perform compilation and review of batch release documentation packages.

•Work independently and within cross-functionally teams and act asSME during external audit/inspections.

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

•Prepares,revises,routes,reviews and approves GMP documents in support of quality assurance cell therapy Operations using strong organizational skills and critical thinking skills.

•Manages the development through EDMS and files/archives documents according to Celgene procedures.

•Works with teams to obtain in-depth understanding of QA processes and their documentation requirements.

•Produces and reviews high-quality documents that meet applicable standards and are appropriate for their intended audience as per FDA/EMA regulatory requirements applicable to biologics,pharmaceuticals.

•Responsible for complaint investigation,resolution,review batch record,environmental monitoring, qc lab data .

•Uploads QA documents to celgene share point sites and additional electronic portals when required.

•Oversight of lot disposition with the quality operations team to ensure timely and compliant release of batches.

•Facilitates review meetings and discussions to maintain documentation project timelines.

•Editor/Owner access to restricted ide-cel batch records to upload and edit BR as part of QA disposition S12.

•Scan batch records software vendor nuance:paper stream capture version 2.7.4.1.

•The technical writer,QC systems and services authoring SOPs,work instructions,tutorials,methods,specifications and revising GMP documents for QC GMP testing at the CAR T manufacturing facility.

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

•Work in a highly regulated environment to follow GDP,GMP electronic documentation systems.

•Work in a collaborative team environment,train others,mentor associates and set priorities for the group.

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

•Strong organizational skills and critical thinking skills helps authors and revises GMP documents.

•Authoring new documents for GMP test execution,equipment training,sample management and software.

•Managing the development of documents through EDMS for the execution of change controls as needed.

•Creating and maintaining documentation projects and timelines as well working with internal teams to obtain an in-depth understanding of QC processes documentation requirements.

• Providing excellence attention to detail when writing or revising documents for producing high-quality documents that meet applicable standards and are appropriate for their intended audience.

•Writing easy to understand instructions and creating tutorials to help end-users train on a variety of activities.

•Applying critical thinking skills when developing documents for new procedures.

•Authored non-validation protocols,validation summary reports,parameter analysis and SOPs for deviations in Veeva,also perform each run‘s QC data package can be scanned and verified.

•Writing and formatting QC documents like bulk gas handling,sample management,test methods and Specifications in veeva also perform verification of scanning binders in veeva to make REC effective.

•Perform calibration of MACSQuant flow cytometer, using vaccum aspirator for removing fluids from the wells without affecting cells helps with 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,facility documents like contamination control, environmental monitoring for production areas in Veeva.

•Worked closely with manufacturing and QC team to perform root cause analysis for product specifications.

•Authored and formatted SOPs and validation summary reports for equipment’s like particle analyzer,water purifier,cell processor,incubators,centrifuges and water baths for refrigerators,freezers in Veeva..

•Analysis for validation parameter precision,accuracy,linearity,LOD/LOQ,robustness,stability.

• Access the source system during HA inspections,internal audits,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 PV practice)for european union, also good practice for data management and Integrity in regulated GMP/GDP environment.

•Responsible for IPV,andotoxin,bb2121,cell process development (assay development),PBMC flow validation protocol supporting SOPs,CD3 linearity data analysis,linear regression plot for T cell percentage.

Novartis,EastHanover,NJ Jan 2019 to May 2019 QA QA Compliance & Regulatory Lead,Cell&GeneTherapy

•To set up the governing documentation for the pilot plant in cell & gene therapy.

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

•Responsible for standards and GXP,CV (IQ/OQ,PQ),regulatory compliance 21 CFR Part 11,CFR 820,Part 1271,Part 211,29 CFR 1904,29 CFR 1910,ISO13485,14001,9000,9001 to meet the requirements of regulatory as per IT-pharma medical device quality and compliance.

•Assists analytical and process science on authoring developmental protocols and reports.

•Co-ordination of timelines,document revisions and review cycles for all GMP documents.

•Manage validation projects within regulated environment,understanding of 21 CFR Part 11.

•FDA GXP requirements and computer system validation documentation with GDP.

•Review of completed batch records and other GxP documents in collaboration with QA 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 co-ordinates review and approvals of the documents.

•Authors,reviews,updates and assists in developing departmental SOPs and qualification documents/programs, also Identify and anticipate risk of non-compliance and address them.

•Analyze QMS metrics and develop recommendations for improvements to the management.

•Ensures that all activities are in compliance with cGMP,HA regulations and the client policies.

Bellerophon Therapeutics,NorthBrunswick,NJ Aug 2018 to Jan 2019

Lead Preclinical Regulatory Affairs

•Member of professional team for commercial deployment of the iNO pulse delivery system of current clinical trials and responsible for Mark-2 device evaluation,calibration,compliance log,testing.

•Knowledge of lean six sigma,continuous process improvement throughout the enterprise.

•Possess experience working in pharma industry in a regulated IT environment with complete drug life cycle Process,ranging from drug discovery,clinical trials,manufacturing to pharma sales and marketing.

•Perform laboratory activities,deployment of high quality,reliability drug delivery system helps medical device verification to follow FDA,risk management,QMS,continuous improvement,regulatory compliance.

•Processing medical device return,servicing,technical evaluations and verification technical activities.

•Work with QMS software QT9 (Automating 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 revision 985.

•Involved in analysis of linear regression of the flow volume and reporting of slope and intercept an error.

Becton Dickinson,FranklinLakes,NJ March 2017 to June 2018

Lead QA Complaince & Regulatory-Projects

•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 and IQ,OQ,PQ for infusion pumps.

•Reading and understanding assembly drawings,manufacturing,test instructions and 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.

•Document test results and communicate with R&D engineers as required,strong technical writing skills for project and regulatory documentation,also participate in gauge R&R studies.

•Provides feedback to medication and procedural solutions (M&PS) research and development,advanced product Development services (APDS),knowledge on testing software,firmware and hardware by test protocols.

•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 and analysis of test methods,competitive analysis,test performed by following test protocol or test instruction.

•Responsible for the testing will help products to meet customer’s expectations and regulatory requirements.

•Product development processes,regulatory,quality requirements and design controls,such as 21 CFR 820.30.

•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.

•Perform measurement system analysis for different products and testing for other medical device.

Bureau Veritas,Linden,NJ Oct 2016 to Feb 2017

Laboratory Inspections Supervisor

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

•Maintaining a GMP and GLP 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.

•Prepares graphs and charts and calibrates laboratory instruments.

ExxonMobil,Clinton,NJ May 2015 to Nov 2015

Project Engineer

•Coordinates and develops with analytical,process science, engineering and QA team qualification projects and plans 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,follow GHS of classification,labeling chemicals,SDS,EHS label creation,near misses.

•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 tests such as density,pour point,cloud point,GC,HPLC,sulfur,viscosity, flash Point,TDS,TSS, Conductivity, pH as per FDA regulation for QA,QC,GMP,R&D and pilot plant programs.

Qatar Energy,Qatar May 2009 to Dec 2014

Operation Engineer Field Development-Projects

Qatar Energy,a billion-dollar energy utility into electric and gas systems and energy efficiency.

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.

Used maximo and continuous improve equipment preventative and corrective maintenance.

Participate for process related matters,reviewing PCR for approval/rejection and carrying out PCR detail engineering and making ipmplementation,SOR evaluation,recommendation and final approval as a focal point.

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

Process design and documentation of activities throughout project lifecycle to meet milestones to maintain KPI.

Reliance Industries Limited,India Aug 1989 to May 2009 Senior Project Manager

Responsible for the start-up,validation and operation of a new manufacturing facility.

Manage external or internal technical transfer activities and lead the implementation of new cGMP processes, equipment and materials,manage complex troubleshooting and problem-solving efforts.

Integrate safety,compliance and quality systems into manufacturing operations and ways of working.

Determine manufacturing KPIs,establish tools to monitor and report metrics and implement actions.

Evaluate employee performance against the individual team and organizational objectives and when appropriate, provide constructive feedback to improve their performance.

Perform and oversee process unit operations described in SOP and batch records.

Complete and review documentation for process transfer protocols,validation protocols,SOP and BR.

Ensure the shift performs tasks in a manner consistent with the safety policies,quality systems.

Lead deviation investigations and support on-time closure of deviations and CAPAs.

Write technically sound manufacturing operating procedures,promote effective and efficient operations.

Work with production planning and area management to establish daily unit operations schedule that includes people,product and material flow across multiple shifts.

Indo-Nippon Chemical Limited,India May 1988 to Aug 1989

Senior Chemist

Work as senior chemist for the Laboratory testing and analysis to direct the plant batch as per the test results.

Responsible for analysis of shore e hardness,tensile strength,color as per american public health association.

Set up R&D reaction with different composition on small scale for different plasticizers.

Education:

Bachelor of Science,Chemistry : Maharaja Sayajirao University of Vadodara (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.

SoftwareSkills:Bentley,novastyle,subway,firstdoc,TDMS,EDMS,ECM,SAP,LIMS,matrikon,ASSAI,PDFnitro,lotus notes,microsoft office,lab view operating systems,microsoft visio,veeva vault,E-notebook,QUADS business analytics tool,celdox,EQRMS product quality complaints,EQRMS deviations/CAPA,EQRMS,global change management,microsoft access,sharepoint,APQR(annual product quarterly review),GMR(global management review),office365,MACSQuantify™software,compliance wire,success factor.

Training: Heart saver first aid CPR and AED,DIAMS,SHE level training,SHE critical equipment,LOTO,oil spill prevention,OIMS,MOC,GHS,webcat,safety in motion,ISO9001,ISO14001,cybersecurity,records management, data privacy,GDP,blood borne pathogens,risk management,celdox editor/owner,celdox next gen author training Placeholder,NJ-EHS-PPE,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,laboratory safety manual,facilities and Equipment’s,hazardous waste,spill response,handling and 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 in analytical development and technical operations,operation/maintenance of pipettes,storage and distribution Operations,general calibration program,global quality system manual,true copy reinforcement.

Projects :

Epic for smokeless flare and automatic blowdown system - green energy.

Epic for corrosion inhibition facilities at wellheads - pipeline distribution for gas.

Epic for fiscal meter with meter proving facility - transfer and distribution of gas.

Procurement,installation and commissioning for new glycol regeneration.

Replacement of old three phase separators.

Automation upgrade from old system to new system - instrumentation.

Contact this candidate