Holly Baldwin Email and Phone Number
Holly Baldwin's Location
Bridgewater, New Jersey, United States, United States
Holly Baldwin's Contact Details
Holly Baldwin work email
- Valid
- Valid
- Valid
- Valid
- Valid
Holly Baldwin personal email
- Valid
Holly Baldwin phone numbers
About Holly Baldwin
Quality & ValidationI have over 24 years of experience in the Life Science Industry (Pharmaceutical, Medical Device and Tissue Regeneration) and in SaaS company as a Computer System Validation authority and resource.Expertise in 21 CFR Part 11 Assessments, Server Virtualization, Cloud Services (SaaS), IT Change Control, Validation Project Management, Testing Strategy (IQ, OQ, PQ, System Integration, UAT), System Development LifeCycle documentation, data migration strategy, Instructional Design and Training; FDA and worldwide Health Authority Audit preparedness, General Data Protection Regulation (EU privacy), Swiss Privacy Regulation; California Consumer Privacy Act of 2018.System Validation experience with Infrastructure, Virtualization, SAP and Oracle Enterprise Systems, Document Management Systems, Labeling systems, Learning Management Systems; Application Development and Testing systems; CAPA systems, FDA gateway for electronic submissions (ESG). Speaker/Trainer21 CFR Part 11 Trainer of China FDA inspectors; May 2018.Lead speaker on 21 CFR Part 11/Computer System Validation seminars in Suzhou and Shenzhen, China, May 2018.Institute of Validation Technology since 2005 on subjects such as Cloud Computing and Validation, Change Control, IT and QA Conflict, Good Testing Practices, Implementing Validation Compliance Training, What is Validation?; Cloud Computing Summit Aug. 13, 2019.American Society of Quality (ASQ) Boston Conference. April 1-2, 2019. The conference focused on quality as a survival strategy in a Digital Era to adapt to the exponential change of technology.I was privileged to be asked to speak at the China Food and Drug Administration's Inspector Training event in Beijing, China on the following topics: 21 CFR Part 11, System Development Life Cycle, Computer System Validation and Quality by Design in May 2018. And while in China - I also was a speaker at 2 other medical device events on the same topics in Suzhou and Shenzhen.
Holly Baldwin's Current Company Details
Holly Baldwin Work Experience Details
-
Digital Test Lead - IcareSanofi Dec 2023 - PresentParis, France, FrDesign, develop, and maintain test scripts and frameworks for GxP and Non-GxP stories.Collaborate with testing and development teams to understand test requirements, design, and implementation details.Identify opportunities for test automation and propose automation strategies to increase efficiency and effectiveness.Develop test plans, test cases, and test data to support efforts.Execute/review tests and analyze test results, reporting and tracking defects as necessary.Continuously enhance and improve existing automation frameworks to increase test coverage and reliability.Integrate tests into the continuous integration and delivery (CI/CD) pipeline.Collaborate with cross-functional teams to troubleshoot and resolve automation issues.Stay updated with the latest industry trends and tools related to test automation and incorporate them into the testing process as appropriate.Mentor and provide guidance to iCare Test team members regarding test automation best practices and techniques.Contribute to the overall improvement of the software development process, including agile methodologies, DevOps practices, and quality assurance strategies.Coordination between internal team and external teams for SIT/UAT and deployment.Work as part of the Agile Team.Responsible for ensuring the integrity and privacy of Personal Identifiable Information (PII) and Protected Health Information (PHI)-HIPAA And GDPR.
-
Manager Quality Validation Csv At Sanofi PasteurSanofi Jan 2020 - Dec 2023Paris, France, FrManager of Computer System Validationat Sanofi Pasteur. We currently supply one billion doses to people around the world eachyear, and work hand in hand with our public health partners so ourvaccines can help protect as many as half a billion lives annually..Our portfolio of vaccines offers protection against a wide rangeof infectious diseases for people around the world. Ranging fromcholera, dengue fever and diphtheria, to haemophilus influenzaetype b, polio, pertussis, tetanus, Hepatitis A and B, meningitis, influenza …to name a few.
-
Manager Quality Validation CsvSanofi Jan 2020 - Jan 2020Paris, France, Fr
-
Adjunct LecturerRegulatory Affairs And Quality Assurance Graduate Program - Temple University School Of Pharmacy Nov 2020 - PresentFort Washington, Pa, Usas a part of speaking at KENX conference in December 2020 on GDPR Compliance Considerations for SAAS and Cloud Services; students at Temple University’s RA/QA Master’s Program; have the opportunity to take an online exam two weeks after the event; and gain 1.5 credit unit hours towards a Master’s Degree -
Hiregenics - Consultant At Bristol Myers Squibb (Nov 11, 2019)Hiregenics Nov 2019 - Jan 2020Duluth, Georgia, Us -
Senior Validation AdvisorUl Pure Learning Dec 2017 - Jan 2020Northbrook, Illinois, UsAdvise life science companies on validation strategies to implement UL PURE Learning's product portfolio. Speaker at Institute of Validation Technology's Computer and Software Validation week. Spoke at medical device forums in China on FDA predicate rules, computer system validation and 21 CFR Part 11 -
Compliance And Validation AnalystUl Pure Learning Dec 2017 - Jan 2020Northbrook, Illinois, Us
-
Compliance And Validation AnalystUl Pure Learning Dec 2017 - Jan 2020Northbrook, Illinois, Us
-
It Software Validation EngineerLifecell An Allergan Company Feb 2017 - Nov 2017Provided validation and project management expertise to the IT Project Team (in US and Global)by developing SDLC documentation, performing Gap Analysis on 21 CFR Part 11 assessments, managing change management for Oracle, ComplianceWire, P2V and V2V activities, Trackwise, asset management system, HP Application Lifecycle Management system, infrastructure, MES, labeling templates and finance systems. Managed OQ and PQ testing strategy and execution for a 13-country Oracle Upgrade project. Received Star Performance Award for this project and for overall validation expertise as to “acknowledge significant contribution to business performance by going above and beyond the call of duty to delight customers, motivate employees or satisfy shareholders.” Trained off-shore and local personnel on "Forming a Relationship between IT and QA" and “What is Validation”.
-
Validation AnalystB.Braun Medical Inc Jul 2004 - Nov 2017Provided validation and project management expertise to the SAP IT Project Team (in US and Global)
-
It Validation AnalystBbraun Jul 2004 - Nov 2015Provided validation expertise to the SAP Project Team by authoring SDLC documentation including: validation document templates, validation master plans, installation qualification protocols, operational qualification protocols, user requirements specifications, functional requirements specifications, SOPs, technical upgrade plans, test plans, test cases, test summary reports, guidance documents and project summary reports. Acted a quality assurance for any SAP Change Controls including advising SAP team members on validation requirements in support of Change Control Requests including: documentation, testing requirements and completion of Change Control Request forms with proper approval. Once all Change Control requirements met, acted as the final approver in SAP for all US transports. Created and conducted training on proper test procedures, basics of validation, proper change control procedures, SAP security and requesting SAP customized reports. Acted as liaison between SAP Functional Team Leads, SAP Business Community and SAP IT teams. Was primary validation and US project lead on several SAP projects including SAP implementation in BBraun’s Mexico facility; SAP Legacy System Upgrade, SAP system relocation to Germany, SAP APO/PM and QM module implementations, Global SAP Upgrade to ERP, SAP bolt-on upgrades and implementation of SAP Business Information Warehouse for Sales. Acted as primary contact for system auditors. Asked to be a speaker at the Institute on Validation Technology on change control topics which included: “Creating Usable Validation Documentation”, "Forming a Relationship between IT and QA", :Creating Quality Test Scripts", "Implementing a Valdation/Compliance Training Compnay-wide" and “Testing and IT Change Control”. Provided training in computer system security, change control, system testing and validation.
-
It ValidationBbraun Jul 2004 - Jul 2004Tested Web GUI database, linking 2 major telecommunications companies, for informational integrity, usage ease and compliance with end-user methodologies. Created testing standards of order entry databases and Web GUI application for customer-interface associates. Evaluated provisioning procedures for several AT&T local services markets in coordination with project work team and incumbent local service providers. Developed approximately 45 operational procedure documents for each of the 4 local market entries. Facilitated procedural walk-through forums with subject matter experts to obtain documentation-accuracy feedback. Analyzed project processes for local service entry teams with written documentation placement in associate on-line informational handbook. Certified field trainers in three regional locations on local service market programs and client applications.
-
It Validation AnalystBbraun Medical Inc Jul 2004 - Nov 2015
-
Systems AnalystSchering-Plough Research Institute 1999 - 2005Kenilworth, New Jersey, Us -
Lead AnalystSchering-Plough Research Institute Oct 2000 - Jul 2004Kenilworth, New Jersey, UsAuthored SDLC documentation for an electronic records indexing/tracking system's upgrades and 21CRF Part 11 Remediation including strategy documents, test plans, test scripts, system design specifications, user and functional requirements, and summary reports. Acted as the liaison between business users and IS project team. Led team of 5 testers and am Test Manager of successful execution of unit and system integration testing for 8 release builds in 2003-2004.Reviewed and edited SOP drafts as a validation subject matter expert in the application development realm. Acted as technical reviewer on SDLC documentation including unit and IQ/OQ test plans, scripts and summary reports. Authored FDA audit preparedness documentation for indexing and tracking system's application development team including system architecture diagram and input/output data flows. Wrote the user and functional requirements document for a label tracking system which incorporated several divisions in the company including manufacturing, regulatory affairs and development operations which resurrected the project to its successful implementation in 2003. Provide Level 3 support for indexing and tracking system, as well as, provided training to Level 1 and 2 Support Teams on troubleshooting basics and system administration. Selected as primary back-up to system's Project Manager and second point of contact in case of FDA audit. Led training of RIS consultants in documentation department's business process and system. Aided Regulatory Affairs in the review of submission critical PDF documents. Evaluated scanning and OCR software to determine usability in regulatory publishing context. Acted as team led for Quality Assurance Analysts testing new releases. Trained new Level 1 and Level 2 Support Team for applications by Oct 2002 while maintaining function as Level 2 support until complete transition.
-
Quality Assurance AnalystSchering-Plough Oct 2000 - Jul 2004As a consultant, performed quality assurance functions on application used for clinical research FDA document submissions. The application was developed using Power Builder 6.5, accessing an Oracle database, and using client server architecture. The system integration is for scanning of Case Report document images using InputAccel with a Documentum data repository. The report generation tool is Seagate Info 7 - Info Desktop application. Second phase of the project entailed data conversion from a legacy MVS mainframe to Oracle. Provided all aspects of the QA function for: indexing system, InputAccel, Documentum, microfilm process, process of transforming scanned TIFF images to PDF files in order to create FDA submission documents, interface application to import CSV files to indexing application and Q-Master print software. Created the user guides, the system administration guide, troubleshooting guidelines and training manuals. Provided Level 1 and Level 2-system support for end-users. Utilized the defect tracking system, SQA Manager. Hired as
-
Lead AnalystMgd Services, Inc Mar 1999 - Oct 2000
-
Training SpecialistNextlink Communications Jul 1998 - Mar 1999UsAs the East Coast Regional Training Specialist for a long distance, local, regional and ISDN telecommunications provider in Central Pennsylvania, I developed training curriculum for customer service, technical and managerial personnel. Created multi-day training course on Coaching and Counseling for management personnel. Developed a training and market entry analysis of an Integrated Services Digital Network (ISDN) and Introduction course of ISDN Services for account executives and customer service representatives. Instituted an OSHA-complaint Safety Training program for Switch Technicians, Networks Engineers and Installation Technicians by becoming a subject matter expert on potential occupational hazards. Launched technical training curriculum concerning the mastery of skills, effecting compensation levels. Received training certification in project management, introduction to telecommunications basics and Achieving Extraordinary Customer Relations (through AchievGlobal -
Performance SupportAt&T Oct 1996 - Jul 1998Dallas, Tx, Us -
Operator Services AssociateAt&T Jun 1989 - Jul 1998Dallas, Tx, UsProvided training to 15 operator services associates on revised procedural methods, new products and services and system applications at a customer satisfaction-testing laboratory. Advised internal clients on potential impacts to associates and customers with the implementation of supplementary operational procedures and new product offerings. Created and presented an operator services overview package for senior staff and external clients to generate a greater business share for the customer satisfaction-testing laboratory. Participated in personnel development training team responsible for the professional and personal advancement of 50 customer contact associates by providing multimedia courses from external vendors. Provided excellent service for approximately 800 long distance customers daily while maintaining strict time limit and courtesy guidelines. Provided translation services for Spanish and Portuguese-speaking customers.
Holly Baldwin Skills
Quality Assurance
Computer System Validation
Fda
Change Control
Software Documentation
Sop
Erp
Program Management
Validation
Documentation
Testing
Gmp
Process Validation
Cgmp
Sdlc
Quality Systems
Pharmaceuticals
Documentum
Medical Devices
Regulatory Affairs
21 Cfr Part 11
Compliance
Coaching
Sap
Business Analysis
Gamp
Problem Solving
Change Management
Software Validation
Cross Functional Team Leadership
Microsoft Office
Sql
Analysis
Team Leadership
Process Improvement
Technology Transfer
Holly Baldwin Education Details
-
Binghamton UniversityLatin American And Caribbean Studies -
State University Of New York - SystemLatin American Studies
Frequently Asked Questions about Holly Baldwin
What company does Holly Baldwin work for?
Holly Baldwin works for Sanofi
What is Holly Baldwin's role at the current company?
Holly Baldwin's current role is Computer System Quality Validation Expert and Test Lead.
What is Holly Baldwin's email address?
Holly Baldwin's email address is ho****@****aun.com
What is Holly Baldwin's direct phone number?
Holly Baldwin's direct phone number is +148426*****
What schools did Holly Baldwin attend?
Holly Baldwin attended Binghamton University, State University Of New York - System.
What are some of Holly Baldwin's interests?
Holly Baldwin has interest in Social Services, Civil Rights And Social Action, Fitness (Part Time Fitness Instructor), Animal Welfare, Arts And Culture, Health.
What skills is Holly Baldwin known for?
Holly Baldwin has skills like Quality Assurance, Computer System Validation, Fda, Change Control, Software Documentation, Sop, Erp, Program Management, Validation, Documentation, Testing, Gmp.
Free Chrome Extension
Find emails, phones & company data instantly
Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial