Experience

QPharma, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director, Integration Validation (QA)

  • Aug 2022 - Present



Selective Insurance

• United States
• Insurance
• 700 & Above Employee

• BSU Business Analyst

  • Dec 2019 - Aug 2022



QPharma, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Managing Director, Ti CRM

  • Jan 2017 - Dec 2019

  SUMMARY: responsible for managing and overseeing all activities related to the Titanium CRM application- from development, validation/testing, sales, client implementation, and daily operations.DUTIES AND RESPONSIBILITIES: · Identifies and designs system requirements. · Communicates system requirements to development team. · Updates Business Requirements Document. · Performs high level system testing. · Attends weekly development meetings. · Oversees validation/testing activities. · Reviews and approves system related documentation. · Assists Marketing team with marketing materials. · Assists Sales with sales demos. · Maintains Sales of Ti CRM. · Oversees Client Ti CRM implementations. · Manages Ti CRM day to day system operations. · Performs Ti CRM training internally. · Performs Ti CRM client training. · Manages Ti CRM operations team. · Creates/updates JIRA tickets related to Ti CRM. · Communicates with other business managers and company executives in efforts to effectively deliver the status of the Ti CRM business. · Ensures business rules and any other required documentation is kept up to date. · Ensures client data is transferred and shared in accordance with the clients' expectations and QPharma standards. · Trains the Account Team and other staff members on any new processes and provides coaching as needed. · Reaches out to clients and new prospects either by phone or in-person meetings to establish opportunities for further business development and growth. · Performs other related duties as assigned by upper management. Show less

• Associate Validation Manager

  • Oct 2012 - Jan 2017

  • Over 12 years of experience in validation development and execution in regulatory compliance projects including Computer System Validations, SOP Development, Laboratory Equipment Validation and Warehouse Facilities Validation.• Project Manager for multiple computer system validations.• Document Coordinator• Administrator to Learning Management Systems• Seasoned Document Remediation and Quality Assurance

• Pharmaceutical Validation Consultant and Contractor

  • Sep 2003 - Oct 2012

  Expertise in authoring Validation Master Plans focusing on the business needs and quality requirementsDevelopment of User Requirements Specification (URS), Functional Requirements Specification (FRS) and Design Specification (DS) documents to detail the system functionalities and business requirementsGenerated and executed validation Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols that have passed FDA inspections.Developed other documentation including Proposals, Validation Master Plans, Traceability Matrices, Technical Reports, Validation Summary and Final Reports to summarize the validation effort and the systems acceptability for use.Remediation of the full life cycle of validation deliverables for an enterprise wide Customer Relationship Management SystemInterviewed user groups to identify and document the requirements to address business needs Responsible for reviewing existing validation effort to ensure compliance with 21 CFR Part 11 and 21 CFR Part 203 regulationsPerformed Quality Assurance review of executed test cases.Developed spreadsheets to organize all documentation, deliverables and anomalies for an Adverse Events system Show less



CSSC

• Validation Specialist

  • Oct 2003 - Sep 2006

  Computer Systems Validation Experience • Developed validation deliverables including IQ, OQ, and PQ for Sales Force Automation and Sample Accountability applications. • Executed validation IQ, OQ and PQ protocols. • Developed other documentation including Proposals, Validation Master Plans, and Traceability Matrices. • Developed Validation Summary and Final Reports. • Remediation of the full life cycle of validation deliverables for an enterprise wide Customer Relationship Management system. • Developed spreadsheets to organize all documentation, deliverables and anomalies for an Adverse Events system. • Oversaw execution, assigned anomalies, and provided status reports to management. • Assisted clients with anomaly resolution. • Performed Quality Assurance review of executed test cases. • Participated in the validation upgrade of TrackWise from V5.9 to V6.0 and a Project Workflow OOS through the complete life cycle of validation deliverables. • Conducted regression testing for an OOS Project Workflow in TrackWise V6.0. • Developed validation deliverables and reports for the CAPA Project Workflow for TrackWise V6.0. Laboratory Equipment/ Software Validation Experience • Gathered information for the generation of User Manuals, Requirements, Specifications, and Standard Operating Procedures. • Generated validation IQ, OQ, and PQ protocols for Laboratory Equipment and Laboratory Equipment Software. Production Equipment Validation Experience • Generated verification documentation for existing pieces of equipment: Qualification Plan, Functional Specifications, and Verification Qualification. • Gathered and researched information for the execution of the Verification Qualifications. • Performed GAP analysis for packaging lines to evaluate the need for re-validation. • Performed GMP applicability assessment on pieces of equipment associated with various packaging lines. Show less