QA, Validation, RA, Master Data Governance and Stewardship, SAP
Resume:
Reshma Nadgauda
805-***-**** *******@*****.***
San Francisco Bay Area, CA
hƩps://www.linkedin.com/in/reshma-nadgauda-35492938/ ObjecƟve
Seeking a challenging and rewarding posiƟon in the field of InformaƟon Management-Technology/Data Governance and Stewardship that will use my Data Analyst / Business Analyst (BA) and Master Data Management (MDM) experience in the Life Sciences / Biotech/PharmaceuƟcal industry and enable me to make a posiƟve contribuƟon.
Professional Summary
Strong Data Analysis and Business Analysis /MDM /QA /ValidaƟon experience in the Life Sciences/ Biotech/PharmaceuƟcal industry. I have over ten (10) years of experience with data modeling, quality process flows, regulatory and compliance direcƟves and interfaced with IM/IT Leads to ensure business needs are met. Ten (10+) years' experience in implemenƟng business requirements into soŌware applicaƟon. Have mapped end-to-end operaƟons, wriƟng, and execuƟng use cases. transiƟoning from Oracle based lnformaƟca/Siperian (legacy) MDM to RelƟo (cloud based) MDM. Ensuring the transiƟon is smooth by maintaining and keeping the data quality, privacy, security, and integrity. Ensuring the enhancements are executed in the ongoing sprints leading to process improvements in the workflow management. Subject MaƩer Expert in Master Data Governance and its stewardship, Quality Assurance and Regulatory Compliance.
EducaƟon BS in Chemistry
Bachelor of Science (specializaƟon: Chemistry) from University of Mumbai (Bombay), India Microbiological TesƟng from NaƟonal Dairy Development Board, Gujarat, India CerƟficaƟons
Greenbelt/ Lean / Agile SAFe
Professional Experience
Business Analysis, Data Governance and Stewardship, Quality Assurance, Regulatory and ValidaƟon, MS Office, G Suite
Genentech/Incedo, South San Francisco, CA Jan 2014 - Mar 2023 Lead Business Data Analyst
Business and FuncƟonal requirement gathering from business users/stakeholders and lead the UAT TesƟng for the new MDM (RelƟo) and CRM (Customer RelaƟonship Management) (Salesforce (SFDC) and VeevaCRM) transiƟon from legacy to cloud-based plaƞorm and tesƟng new enhancements.
SME and Point person of contact for technical and funcƟonal implementaƟon, data integraƟon from various sources and resolving incident management for business end users.
Leading the mapping and documenƟng end to end MDM operaƟons process flow to support transiƟon and release of MDM from one plaƞorm to another.
Write and PrioriƟze user stories aŌer requirement gathering by understanding the product vision and goals of the project.
Write and execute test plans, test cases and test results for UAT tesƟng.
SME on the HyperCare team to support the end user aŌer a major change in operaƟons to improve customer retenƟon and saƟsfacƟon to increase product adopƟon. Helps in geƫng customer feedback to incorporate enhancements in the ongoing sprints for the next release.
Translate the end user requirements to the back-end team to incorporate changes to enhance their UX/UI experience.
DocumenƟng any process enhancements in backlogs and ensuring they are executed using Agile SAFe PM methodology.
Customizing tasks to meet specific needs and integraƟng them into the workflow for process improvements by acquiring Python scripts from the Global AnalyƟcs and Technology CoE (GATE) team. This allowed for automaƟon of data processing and analysis, and enhanced everyday tasks through automaƟon.
Manage SAP Master Data objects like Material Master, Quality Master, Sales Views, BOMs (Bills of Material), Change Management etc.
Used MS Excel, MS Access and SQL with RelƟo 360 to add, modify and retrieve data. Matching and merging for data was done in RelƟo 360. Bulk UƟlity was used to upload huge amount of validated data into RelƟo 360 MDM.
Lead and guide a team of 9 members (2 onshore and 6 offshore) and make sure all deliverables of assigned tasks for the stakeholders are met on Ɵme.
SME and Point person of contact for data governance, stewardship, cleansing and its maintenance for metadata gathered by business end users for sales, payer, customer master data alignment, clinical data captured through IDBS LIMS and eLN and drug formularies datasets.
Run daily standup meeƟngs to ensure all deliverables are met on Ɵme and miƟgate any gaps by ensuring they are closed in a Ɵmely manner.
Manage Stewardship of components of MDM database related to verificaƟon/validaƟon of Healthcare Professionals and Health Care OrganizaƟons and their affiliaƟons for Salesforce CRM and Veeva CRM source party keys.
EffecƟvely manage IQVIA HCOS reconciliaƟon/validaƟon acƟviƟes for Healthcare OrganizaƟons and their HCP to HCP and HCP to HCO affiliaƟons and Payer affiliaƟons.
Managing the Data Stewardship Process by evaluaƟng the unstewarded spend recipient (Veeva YTD reject/pending report for Healthcare Professionals, prioriƟzing by spend/Ɵers for aggregate spend reporƟng for annual federal and state reporƟng.
Recommend process improvements as needed.
Responsible for submiƫng and monitoring inquiries, resoluƟon accuracy, and Ɵmeliness of responses for escalaƟons from IQVIA MedPro and Veeva
Manage the incoming files from IQVIA LAAD and SHA claims and MCO (Managed Care OrganizaƟon)
/ACO (Accountable Care OrganizaƟon) data
Perform searches as needed in internal systems (InformaƟca Siperian Lookup tool), RelƟo 360 and external systems MedPro, IQVIA Customer Portal and NPPES and web searches.
Manage the progress of 12 different HCO/HCP DCR (Data Change Request) record types and ensure Ɵmely resoluƟon.
Ensure target lists/ data gathered through ETL are uploaded with the highest accuracy in the JAMS
(Javelin Alignment Management System) interface. Interact with the ZS Associates offshore team as required.
Manage and ensure monthly account and address merges are evaluated and completed on Ɵme.
Matching and merging of aƩributes / data sets to be reflected in MDM through MDM tools.
Communicate with data stewards to understand data issues and guide them by explaining soluƟons as required.
Document all processes for training purposes and establish/maintain the Standard OperaƟng Procedures
Ensure all work is completed on-Ɵme and on-target uƟlizing only approved resources.
Develop and maintain excellent working relaƟonships with customers, partners, and other stakeholders.
Provide weekly status reports to the client on the number of issues handled, overall resoluƟon status.
Experience working with visualizaƟon tools like Qlik sense, Tableau, Power BI, Open-source tools, and web applicaƟons.
Experience working with data warehouse, data lake, and data analyƟcs using MS Excel and MS Access.
Familiar with logging bugs and closing them aŌer priority changes / soluƟons / enhancements are implemented with Jira.
Used MS PowerPoint / Lucid Chart for documenƟng end to end flow charts for MDM.
Used Google Suite for collaboraƟve producƟvity.
Computer skills for MicrosoŌ Office - Excel, Word, PowerPoint, Outlook, Access and Visio, ETL, SQL, SharePoint, G Suite.
Amgen Inc/Advanced Biologic SoluƟons, Thousand Oaks, CA Jun 2013- Dec 2013 Sr. Associate, MDM
Managing the entry, maintenance and adherence to standard design and accuracy for Material Master Views, Quality Master Views, and Sales Views for data requests through the SAP ECC workflow process.
Ensure quality of data entry in SAP
Provide business process guidance to internal clients on the workflow process of SAP.
Support tesƟng of workflow in the ERP system in accordance with scheduled Ɵmelines.
Uphold global master data governance process.
Seek out OperaƟonal Excellence OpportuniƟes.
Accountable for achieving data accuracy targets and service level agreements for internal metrics reporƟng.
Understanding of basic supply chain concepts and Amgen commercializaƟon process.
Material, ProducƟon, Planning Master data and/or Quality Management and InspecƟon plan experience in SAP.
Working knowledge of industry regulaƟons, GxP, compliance and pharmaceuƟcal processes.
Evaluate and adhere to company standard operaƟng procedures as well as hold others accountable to SOP adherence.
Determine root cause analysis of problems of moderate scope and complexity.
Leverage OperaƟonal Excellence methodologies to improve processes and decision making.
Ownership in driving tasks and project deliverables to compleƟon.
Communicates in a clear, concise, and Ɵmely manner to clients' requests.
Readily adapts to and manages change.
Understanding of database fundamentals.
Ability to mulƟ-task and support a diverse internal customer base. Baxter Bioscience, Thousand Oaks, CA - Full Time Feb 2002 - May 2013 QA Analyst II
Facility Labeling Lead to manage Labeling and Artwork changes for Final Container and Bulk Drug Substance.
Working in Quality Assurance for Review of FormulaƟon and Finishing Runsheets, QC lot results ensuring all documentaƟon is in Compliance to cGxPs (current Good PracƟces), GLPs (current Good Laboratory PracƟces), and SOPs (Standard OperaƟng Procedures). Ensure all steps are documented; processes performed are within limits, all required tesƟng has been performed and specificaƟon/product license requirements have been met, all non-conformance reports are closed before approving and execuƟng release of Final Container Product ensuring the quality, safety, and efficacy, with knowledge of cGxP (US, EU, Canada, Japan).
Responsible for ensuring correct product status in Oracle JD Edwards (ERP) database (e.g. QuaranƟne, Hold, Released, Reject etc.) for product orders.
Review tesƟng and log defects/excepƟons in the Quality Center.
Review QC tesƟng and disposiƟon lots in SQL LIMS (Laboratory InformaƟon Management System).
InteracƟng with all levels of Manufacturing, QC, QA, Planning and Regulatory Affairs to ensure Ɵmely Release of Product ensuring QA Compliance.
Lead InvesƟgator to review and approve non-conformance reports within respecƟve areas and write invesƟgaƟons pertaining to product complaints and returns.
Interface with inspectors during FDA (Food and Drug AdministraƟon), Corporate and Internal Audits.
Complete responses and closure of commitments for Audits.
Publish Annual Product Review (APR).
Involved in Quality Systems through Change Control, Document Control, Non-Conformance Management, Supplier Quality etc.
Understanding of AsepƟc Manufacturing process.
Maintain a database for individual lots, update monthly release metrics and present agendas in weekly planning meeƟngs to ensure uninterrupted product supply to paƟents.
Review data for/by regulatory submissions.
Write and revise SOPs to be compliant with cGxP/Product License requirements.
Preparing/Reviewing the Test CerƟficaƟons and Protocols that summarizes the results of the Final Container Product.
Qualified Trainer to train new employees.
Computer skills for MicrosoŌ Office - Excel, Word, PowerPoint, Outlook, Access, and Visio.
CerƟfied in Project Management Methodology and CAPA (CorrecƟve and PrevenƟve AcƟon) for non- conformances related to product returns and complaints due to adverse reacƟons.
CerƟfied Lean Green Belt Instructor and Lead InvesƟgator. Systems and ApplicaƟons used:
Oracle JD Edwards for Enterprise Resource Planning (ERP) Materials Management and Lot release.
Oracle SQL LIMS (Laboratory InformaƟon Management SoŌware) for Lab tests and results.
Cerity ECM from Agilent technologies for data management (storing excel, pdf and word files).
Trackwise EQMS (Enterprise Quality Management Systems) for non-conformances and QTS (Quality Tracking Systems) Trackwise for Supplier Quality.
SAP crystal reports for designing /extracƟng data from various applicaƟons like JD Edwards and SQL LIMS to generate reports.
OSI Pl systems store real-Ɵme data and events so manufacturing reports and trends can be generated. It is a historian to store all manufacturing processes. CiƟrx server is used to review the manufacturing processes later by QA.
Product lifecycle management (PLM) to review and approve workflows for SOPs, Manuals and Change Requests for Change Management.
Contact this candidate