David Roach Email & Phone Number

Bagsværd, DK

• Managing a diverse team of IT System Managers, Validation and Compliance Specialists that span all plant operations (Aseptic Production, Finish Product Assembly, Finished Product Packaging, Quality Control, Facilities.
• Supporting site project portfolio on compliance related issues and work with my team to provide key project deliverables for all site project initiatives for IT Systems, Infrastructure systems, and computerized equipment
• Working as part of global integration teams to help shape the new global Manufacturing IT organization

Bagsværd, DK

• Data Integrity project lead for QC and IT systems. Identified gaps in data integrity, workshopped system data lifecycle mapping, implemented security software to limit access on legacy systems.
• Updated segregation of duties on systems as required to remediate DI gaps
• Implemented IT/quality risk management assessments with focus on ALCOA+ principles
• Organized/Performed audit trail review assessments to identify critical actions requiring review
• Managed change controls to close DI gaps and update relevant validation documentation
• Controlled IT system access, and implemented training pre-requisites into access request system

Bagsværd, DK

• Managed scope, schedule, and budget for IT Infrastructure projects supporting aseptic and finished product manufacturing (Infrastructure backbone for MES, SCADA, and site critical systems)
• Assembled teams for major projects and worked with SMEs to take projects from the idea phase to the execute phase (projects include: SCADA Upgrade, IT Security Program, and Storage and Virtualization Infrastructure.
• Managed teams ranging in size from 5-10 core team members
• Managed major IT project budgets ranging from 0.3 to 2.9 million USD
• In addition to delivering on project objectives, empower and coach team members to simplify complex IT systems/processes

Tel-Aviv, IL

• Authored validation deliverables (validation plans, user requirements documents, hardware design specifications, validation summary reports, functional risk assessments) for globally deployed laboratory systems
• Reviewed validation deliverables authored by junior team members
• Served as Business Owner for enterprise controlled document management system (FirstDoc)
• Worked as Subject Matter Expert (SME) for the implementation of HP Application Lifecycle Management software to be used globally across all 70 Teva sites
• Managed IT Change Controls for laboratory systems in the Teva Americas sites
• Served as a validation and IT expert for internal, external, and FDA audits

Tel-Aviv, IL

• Functioned as project manager for validation and implementation of lab instrumentation for Quality Control across Teva North America
• Authored validation deliverables and managed instrument and software implementations
• Gathered user requirements, authored, and executed test scripts for validation
• Ensured software and PC setup were 21 CFR part 11 compliant
• Administrated lab equipment and enterprise software across Teva North America( Empower, TotalChrom, SQL*LIMS, Agilent ICP-MS, ECM, TPW, Tiamo, Omnic FTIR, among others)
• Managed Microsoft Windows Active Directory groups and users

Tel-Aviv, IL

• Authored laboratory investigations (using root cause analysis), protocol, and change control reports
• Performed QC analysis of finished product and raw material samples by HPLC, GC, UV/VIS, NIR, FTIR, etc.
• Executed product method transfers
• Audited laboratory data, recorded results, and analysis reports
• Used LIMS (SQL*LIMS and Labware) to track laboratory results
• Trained less experienced analysts

Alberta, VA, US

• Instructed evening chemistry classes and labs
• Prepared PowerPoint presentation and lectures for each class
• Managed 20+ students per class

Blacksburg, VA, US

• Performed ATR-FTIR to model surfactant removal of BSA protein from an ATR crystal.
• Determined surfactant properties, performed measurements and interpreted resulting data.

Chicago, IL, US

• Provided excellent customer service.
• Handled customer problems.
• Sold merchandise in a competitive environment.

Master'S Of Science, Analytical Chemistry

Bachelor'S Of Science, Chemistry