Pradip Brahmbhatt adya0c@r.postjobfree.com 815-***-****

Professional Experience

15+ years experience in the Pharmaceutical and Medical Device industries. 15+ years experience with Product Life Cycle Management (PLM) systems 15+ years experience supporting FDA, Internal, and ISO audits and inspections. Technical Skills

SAP, EDMS/QDMS, LMS (Intellum, Agile, ComplianceWire), Microsoft Office, MS Project, Crystal Reports, Clientele, Software Test Execution, Oracle based applications (EBS, Siebel, Agile), TrackWise, Documentum, AODocs

Education/ Certifications

Associate Degree, Computer Information Systems, McHenry County College, Crystal Lake, IL US Tech Solutions, Jersey City, NJ Remote June 2021– Present Business Systems Analyst (Contract Position with Google Health) Serve as a primary point of contact for control of Google Health documentation including Manuals, Policies, Procedures, Work Instructions, Training Materials (LMS Intellum), Records, Forms, Regulatory Standards & Templates (AODocs EDMS)

• Current LMS Intellum Administrator, duties include onboarding users, & folder structure changes. Provide user training to the LMS Intellum system.

• Generate reports and update metrics regarding the compliance and effectiveness of the system. Provide timely reports to stakeholders to determine if users are compliant with training requirements.

• Contribute to the weekly LMS Intellum vendor meetings for process improvements & troubleshooting.

• Ensure compliance of document control processes with Google Health SOPs and Work Instructions

• Provide administrative oversight to the document control processes so users can efficiently use Google Health document management tools including; review of change orders prior to routing, sending notifications to approvers to ensure timely document review, prepare and release final versions of documents, & review/upload records.

• Provide technical process/tool support for Google Health users regarding document control & management.

• Help establish and maintain metrics regarding the compliance and effectiveness of the document

• Maintain SOPs, WIs and Forms associated with the AODocs Document Control process.

• Participate/lead in validation of electronic Document Control tools

• Responsible to maintain current regulatory standards and templates online Fresenius Kabi, Lake Zurich, IL Remote Aug 2020 – May 2021 Quality Data Specialist (Contract Position)

Update Product Specification Data within SAP system. This encompasses the following:

• Review CN in Documentum for revised product information from Site or Quality Unit US Operations departments and e valuate impact on SAP Data

• Update appropriate modules within SAP with revised data & notify appropriate personnel of updates Create Interim (new) BOMs. This encompasses the following:

• Coordinate with Product & Packaging Development & Tech Transfer to collect data required.

• Prepare initial BOM and circulate for review and approval

• Upon BOM approval, enter components into SAP and perform revisions until final BOM is in SAP Update BOMs within SAP system. This encompasses the following:

• Receive CN/DCN for changes from Site or Quality Unit US Operations Documentation department

• Incorporate changes in BOMs and route to Quality Assurance Manager for review and approval

• Review supporting documents for final DCN approval Assign and Maintain Component Part Numbers within SAP. This encompasses the following:

• Receive request for new component part number and review against currently assigned numbers

• Issue new component part numbers when needed and process documentation according to SOPs

• Maintain database for ease of tracing part number information Catalent Pharma Solutions, IL Remote June 2020 – Aug 2020 Quality Management System Specialist (Contract Position)

• Document Management System Administration in Documentum and oversight support

• Receive and format submitted GMP documents for final approval through Change Notice (CN)

• Post for approval and issue for training in ComplianceWire.

• Create training modules, assign training and oversee training compliance

• Change Control Administration and oversight support

• Work with the Global System Owners to create/maintain QMS and program metrics reports. Best Western Hotel, Woodstock, IL Sept. 2017 – Feb. 2020 Manager/Owner

• Responsible for quality assurance aspects of products and services to the customers.

• Manage all aspects of the hotel environment through a team of assistant managers

• Contributes to the successful development of the Hotel Staff.

• Builds and maintains relationships with key Clients.

• Manage purchasing of the hotel inventory

• Process financial transactions and manage the business office. Fresenius Kabi, Lake Zurich, IL Aug 2016 – Sept. 2017 Quality Data Specialist

Update Product Specification Data within SAP system. This encompasses the following:

• Review CN in Documentum for revised product information from Site or Quality Unit US Operations departments and e valuate impact on SAP Data

• Coordinate effectivity date of changes with Quality Unit US Operations Documentation group

• Update modules within SAP with revised data and notify appropriate personnel of updates Create Interim (new) BOMs. This encompasses the following:

• Coordinate with Product & Packaging Development, and Tech Transfer to collect initial data required.

• Prepare initial BOM and circulate to appropriate departments for review and approval

• Upon BOM approval, enter components into SAP and perform revisions until final BOM is in SAP Update BOMs within SAP system. This encompasses the following:

• Incorporate changes in appropriate BOMs and route to Quality Assurance Manager for approval

• Review supporting documents for final DCR approval Assign and Maintain Component Part Numbers within SAP. This encompasses the following:

• Receive request for new component part number and review against currently assigned numbers

• Issue new component part numbers when needed and process documentation according to SOPs

• Assign and Maintain GTIN and NDC Numbers within SAP and notify to appropriate departments. Abbott Diagnostics Division (ADD), Lake Forest, IL Apr 2016 – Aug 2016 QA Specialist III (Contract Position)

• Coordinated department change requests for creation and revisions in EDMS (APLM).

• Assisted with compilation, analysis and review of Global Management Review data.

• Conducted QA review of various types of files and records for completeness and accuracy. Celgene, Melrose Park, IL July 2015 – Nov 2015

QA Specialist (Contract Position)

• Created/revised documents & routed in Documentum

• Assisted with compilation, analysis and review of Global Management Review data.

• Authored and updated change requests and released change requests in Documentum.

• Assisted with tracking projects such as the gap assessments and self-inspections.

• Assisted with review of changing regulations.

AbbVie, North Chicago, IL Jan 2015 – July 2015

Compliance Specialist (Contract Position)

• Worked with Compliance-group senior staff to conduct document/system change control processes.

• Authored/updated change requests, reviewed changes & released in Documentum.

• Reviewed and managed technical documents, reports and files in electronic systems to ensure regulated information was documented.

• Learning Management System (LMS): Created, revised, and maintained training curriculum

• Manage user accounts & support end users in LMS. Generated compliance reports for management.

• Assisted during FDA, Internal, and ISO audits and inspections. Lake Region Medical (Accellent), Wheeling, IL Apr 2013 – Dec 2014 QMS Specialist

• Provided QMS oversight to drive effective process and documentation management controls.

• Compiled and maintained controlled documents and related files to release blueprints, drawings, and engineering documents to manufacturing and other operating departments.

• Oversaw the adequacy of documentation of quality records (Complaints, CAPAs, NCRs, ECRs, DHRs, Validation files, training records, NCRs, Deviations, and SCARs).

• Participated in FDA & ISO audits.

Natus Medical, Mundelein, IL Feb 2009 – Apr 2013

QA Specialist

• Responsible for driving and/or championing quality systems and related projects including improving current training system, change control processes, quality tracking systems, and Software testing.

• Subject matter expert in Agile Electronic Documents Management System (EDMS): (CAPA, Change Control, Deviations, Audits, NCR, Training and Customer Complaints).

• Supporting role in the customer complaints process (open, close, investigate, filing).

• Managed all training components for implementation of Agile Electronic Training Records. Catalent (Cardinal Health Spin-off), Woodstock, IL June 2005 – Aug 2008 System Administrator/Training Coordinator

• Responsible for project management, system administration and training compliance in LMS ComplianceWire .

• Implemented three corporate Electronic Document Management System (EDMS): TrackWise (CAPA, Change Control, Deviations, Audits, and Customer Complaints), ComplianceWire for Training Records and CBT, and Documentum for SOP and forms.

• Managed training components for implementation of EduNeering/ ComplianceWire systems for 250 users.

• Investigated and resolved customer complaints by reviewing batch records, and maintenance logs.

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