Emma O' Regan
Senior Technical Lead, QC Lab Systems
Carlow
Summary
Quality-driven Technical Lead well-versed in the pharmaceutical/biologics industry best practices, project management requirements and laboratory data systems support operations. Successful at building robust solutions for changing business needs. Driven professional enthusiastic about meeting market challenges with scalable technologies.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Senior Technical Lead, QC Lab Systems
BMS Cruiserath
6 2023 - Current
- SMLIMS Backup Business Owner
- Providing technical support in the development and maintenance of various QC lab systems user workflows to support various site manufacturing, stability, method transfer and nonroutine testing activities to ensure compliance with procedures, methods, specifications, sampling plans, and data reporting requirements for raw material, water, microbial, biologics drug substance and/or biologics drug product testing
- Create and maintain lab systems by executing the appropriate change management process to support laboratory testing activities and to ensure business, project and/or investigation/CAPA timelines are met
- Support review of change controls associated with lab systems, identify system impact, and develop appropriate change actions required to support implementation of the change, including impact to interfacing systems
- Execute and document appropriate change control and/or verify changes executed by a team member are accurate associated within the lab system
- Review method/specification changes and work with appropriate SMEs to assess impact to lab systems data set up
- Test changes/enhancements through dry runs and receive feedback from lab users, when required
- Setup verification testing as appropriate for the lab system
- Execute User Acceptance Testing for system functionality changes
- Communicate impact of lab system changes to integrated systems areas (i.e
- Trending system, MES, etc)
- Collaborate/liase with appropriate laboratory, manufacturing, analytical support and/or site/global IT teams to ensure needs and requirements are accurate in the lab systems
- Evaluate, recommend and implement processes to improve compliance and the efficiency of laboratory testing operations (i.e
- Visibility to testing queues, testing metrics monitoring, etc) to support product release, new products, and key performance indicators/lean lab metrics
- Contribute to the development/maintenance of processes for effective communication/visual dashboards for lab system work in progress and tracking team metrics
- Assist with compiling/tracking team metrics
- Author, revise, and/or review procedural documents, such as SOPs and WIs and contribute to the development of associated training content
- Train users and less experienced staff on use of lab systems
- Provide ad hoc support to users for issues/questions on the lab system
- Communicate technical issues and activity status updates to team members/direct management
- Process user account requests for system access
- Maintain up to date knowledge on lab system functionality and apply functionality to improve system use and ensure efficient user experience within the systems
- Participate on/Lead teams in support of business process improvements/operational excellence
- Assist with management of the day-to-day activities and prioritization of work, as business needs require.
Consultant, Network QC, Lab Data Systems & Equipment
BMS Cruiserath
07.2021 - 06.2023
- Providing technical support in the development and maintenance of various QC lab systems user workflows to support various site manufacturing, stability, method transfer and nonroutine testing activities to ensure compliance with procedures, methods, specifications, sampling plans, and data reporting requirements for raw material, water, microbial, biologics drug substance and/or biologics drug product testing
- Create and maintain lab systems by executing the appropriate change management process to support laboratory testing activities and to ensure business, project and/or investigation/CAPA timelines are met
- Support review of change controls associated with lab systems, identify system impact, and develop appropriate change actions required to support implementation of the change, including impact to interfacing systems
- Execute and document appropriate change control and/or verify changes executed by a team member are accurate associated within the lab system
- Review method/specification changes and work with appropriate SMEs to assess impact to lab systems data set up
- Test changes/enhancements through dry runs and receive feedback from lab users, when required
- Setup verification testing as appropriate for the lab system
- Execute User Acceptance Testing for system functionality changes
- Communicate impact of lab system changes to integrated systems areas (i.e
- Trending system, MES, etc)
- Collaborate/liase with appropriate laboratory, manufacturing, analytical support and/or site/global IT teams to ensure needs and requirements are accurate in the lab systems
- Evaluate, recommend and implement processes to improve compliance and the efficiency of laboratory testing operations (i.e
- Visibility to testing queues, testing metrics monitoring, etc) to support product release, new products, and key performance indicators/lean lab metrics
- Contribute to the development/maintenance of processes for effective communication/visual dashboards for lab system work in progress and tracking team metrics
- Assist with compiling/tracking team metrics
- Author, revise, and/or review procedural documents, such as SOPs and WIs and contribute to the development of associated training content
- Train users and less experienced staff on use of lab systems
- Provide ad hoc support to users for issues/questions on the lab system
- Communicate technical issues and activity status updates to team members/direct management
- Process user account requests for system access
- Maintain up to date knowledge on lab system functionality and apply functionality to improve system use and ensure efficient user experience within the systems
- Participate on/Lead teams in support of business process improvements/operational excellence
- Assist with management of the day-to-day activities and prioritization of work, as business needs require.
Specialist, Quality, QC Systems and Instrumentation
MSD Ireland (Carlow)
05.2018 - 07.2021
- Worked as part of the cross functional QC Laboratory Systems and Instrumentation group
- Support to all departments including QC Microbiology, Quality Control, Quality Operations and IPT for issues pertaining to LIMS, Empower and SAP, subject matter expert for these systems
- Delivering systems training to new hires and as additional roles are required for existing personnel
- Developing and testing of systems master data
- Providing and maintaining user access accounts for systems
- Performing new master data builds, for the introduction of new products in line with analytical change control requirements to ensure the functionality is available in line with site schedule requirements
- Provide technical support to all users at MSD Carlow
- Liaising with Global systems working groups
- Ensuring DI (data integrity) requirements are verified and maintained for the life of the lab systems on site
- Representing local teams in relation to Laboratory systems design and implementation in conjunction with global teams
- Executing User Acceptance Testing for system functionality changes
- Test changes/enhancements through dry runs and receive feedback from end users, where required
- Management of new Products or new test builds using initiative and with minimal supervision
- Responsible for executing the appropriate change management process to support laboratory testing activities and to ensure business, project and/or investigation/CAPA timelines are met
- Provide subject matter expertise in relation to Laboratory Systems
- Working on improvement projects in relation to LIMS and other laboratory systems as required
- Actively identify and progress continuous improvement opportunities
- Ensuring strict adherence to site policies/procedure and good manufacturing practices
- Execute changes in the laboratory systems independently, proactively identify problems, troubleshoot issues, and develop potential solutions
- Coach and guide colleagues onsite and in the network on the use of Laboratory Systems
- Interpreting customer needs, assessing requirements, and identifying solutions to non-standard requests
- Ensure highest safety standards
- Ensure that the team receives appropriate resources and programmes to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role
- Team representative for all Site and Global GCM Trackwise Change Controls identifying systems impact assessments and implementation of changes as defined within change requirements
- Developing and maintaining training programs for system end users
- Ensure compliance with Merck Global Policies, Procedures and Guidelines, regulatory requirements and execute current cGMP in the performance of day-to-day activities and all applicable job functions
- Responsible site Project manager for implementation of new GLIMS software version, working with Global teams and sister sites
- Project Management for GLIMS Stability Module Deployment at MSD Carlow, ensuring all timelines set out were met and issues escalated to Global Support roles.
Quality Control Associate Specialist
MSD Ireland (Carlow)
08.2015 - 05.2018
- SAP Master Data process steward ensuring all material Quality Management fields were created in accordance with material introduction schedules for Drug Substance, Drug Product, Raw Materials/Excipients, Packaging Components and Critical Support Materials
- SAP Master Data process steward to ensure all material inspection plans were created in accordance with material introduction schedules for Drug Substance, Drug Product, Raw Materials/Excipients, Packaging Components and Critical Support Materials
- SAP Master Data process steward to ensure all material COA profiles were built in compliance with Analytical Standard release requirements for batch release
- GLIMS Site Admin, Business Admin, and Supervisor trained
- Supporting the reviews both Technical and Business of all GLIMS builds
- EMPOWER Site Admin trained
- Liaising with Supply Chain Management department and QA for QC release requirements of new Incoming Materials
- Involvement in initiating/investigating deviations and CAPA implementation, including completion of Fishbone diagrams, 5 why's etc
- Coordination of the creation/updates to Analytical standards for raw materials/components/API(Drug Substance) and Final Filled Product
- Completing impact assessments for Analytical standard updates/analytical change controls and shelf-life changes related to processes initiated by off-site change owners
- Generation, update and review of QC Test Specification documents to aid compliant QC release of materials, including Drug Substance and Drug Product
- Support with audit/inspection requirements to ensure department compliance/readiness
- Participate in internal and external audits and inspections
- Change Control generation and closeout (Trackwise)
- Coordination of QC equipment projects by liaising with vendors and cross functional departments
- Review of Incoming Drug Substance and Drug Product CoA's including result entry on SAP
- Providing training and support to QC department where required.
Quality Control Technician
MSD Ireland (Carlow)
06.2012 - 08.2015
- Cleaning verification and validation analysis for Total Organic Carbon and Conductivity, including result entry and review/approval on LIMS
- Involvement in initiating/investigating deviations and CAPA implementation
- Generation and update of Standard Operating Procedure (SOP's) and Standard Working Instructions (SWI's)
- Generation, update and review of QC Test Specification documents to aid compliant QC release of materials
- Change Control generation and closeout (Trackwise)
- QC sampling of Primary Packaging Components, Detergents/Excipients, Drug Substance, and Raw Materials
- Incoming inspection of Primary Packaging Components including review and approval of Inspection Reports
- Ensuring all testing activities comply with cGMP
- Ensuring all tasks carried out are in compliance with all safety and environmental requirements
- Liaising with external test laboratories to ensure timely testing of samples and any deviation resolution
- Timely and effective testing of samples in accordance with schedules and policies, procedures, and guidelines
- Liaising with cross-functional departments for shipping of samples to external laboratories
- Liaising with Supply Chain Management and QA for QC release requirements of new Incoming Materials
- Review of Incoming Drug Substance and Drug Product CoA's including result entry on SAP.
Education
Bachelor of Science - • Bioscience With Biopharmaceuticals (Honours)
Institute of Technology Carlow
Carlow, Ireland 04.2001 -
Skills
Data Management including Master Data Management across several laboratory systems
User Acceptance Testing (UAT) scripts, authoring and executing
Project Management
Laboratory System Business Owner
Cost-benefit analyses
Specification Writing
Budget Administration
Corrective Action Implementation
Decision-Making
Analytical Thinking
Time Management
Teamwork and Collaboration
Problem-solving abilities
Excellent Communication
Attention to Detail
Task Prioritization
Staff Training
Policy Implementation
Issue investigation
Quality assurance standards
Current Position Start Date
06/12/23
Locations
Cruiserath Road, Mulhuddart, Dublin, 15, Ireland
Jobtitle
Senior Technical Lead, QC Lab Systems
Certification
Lean 6 Sigma Yellow Belt Certified
Timeline
Consultant, Network QC, Lab Data Systems & Equipment
BMS Cruiserath
07.2021 - 06.2023
Specialist, Quality, QC Systems and Instrumentation
MSD Ireland (Carlow)
05.2018 - 07.2021
Quality Control Associate Specialist
MSD Ireland (Carlow)
08.2015 - 05.2018
Lean 6 Sigma Yellow Belt Certified
02-2015
Quality Control Technician
MSD Ireland (Carlow)
06.2012 - 08.2015
Bachelor of Science - • Bioscience With Biopharmaceuticals (Honours)
Institute of Technology Carlow
04.2001 -
Senior Technical Lead, QC Lab Systems
BMS Cruiserath
6 2023 - Current
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