David Roach Email and Phone Number
IT Compliance Manager, Manufacturing IT - Injectable Finished Products at Novo Nordisk at
@
Novo Nordisk
David Roach's Location
Clayton, North Carolina, United States, United States
David Roach's Contact Details
David Roach work email
- Valid
- Valid
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David Roach personal email
n/a
About David Roach
David Roach is a IT Compliance Manager, Manufacturing IT - Injectable Finished Products at Novo Nordisk at Novo Nordisk. He possess expertise in hplc, analytical chemistry, ftir, change control, chemistry and 40 more skills. He is proficient in Spanish.
David Roach's Current Company Details
Novo Nordisk
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IT Compliance Manager, Manufacturing IT - Injectable Finished Products at Novo Nordisk
David Roach Work Experience Details
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It Compliance Manager, Manufacturing It - Injectable Finished ProductsNovo Nordisk Jun 2022 - PresentBagsværd, 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, Business Support Systems, etc.)• 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
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Senior It Systems Manager, It System Management & ValidationNovo Nordisk Oct 2019 - Jun 2022Bagsværd, 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• Presented documentation and systems during audits• Authored data integrity assessments for QC and IT systems• Reviewed and approved validation testing executed in HP ALM
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Project Manager Ii, It & AutomationNovo Nordisk Jan 2018 - Oct 2019Bagsværd, 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 Upgrade)• 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
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It Business Analyst Ii, Global Laboratory Systems Center Of ExcellenceTeva Pharmaceuticals Nov 2016 - Jan 2018Tel-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 • Served as a core member of multiple multi-national project implementation teams• Authored SOPs, Work Instructions, and contributed to the creation of IT standards and policies• Worked with Teva Americas sites to execute remediation plans to bring site GxP computerized systems up to FDA, EU, and GAMP5 standards• Ensured validated systems met Teva’s data integrity standards -
It Business Analyst I/Ii, Teva Americas Laboratory Information ServicesTeva Pharmaceuticals Nov 2010 - Oct 2016Tel-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 • Introduced and authored scripts for file backup and data integrity• Authored IT change controls for lab systems using Trackwise, GxPharma, MKS, and PTC• Ensured validated systems met Teva’s data integrity standards
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Qc Chemist I/IiTeva Pharmaceuticals Jan 2006 - Nov 2010Tel-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
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Adjunct Chemistry InstructorCentral Virginia Community College Jan 2006 - Dec 2010Alberta, Va, Us• Instructed evening chemistry classes and labs• Prepared PowerPoint presentation and lectures for each class• Managed 20+ students per class -
Research Assistant For Unilever At Virginia Tech Department Of ChemistryVirginia Tech Jun 2004 - Dec 2005Blacksburg, 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. -
Commissioned Sales ProfessionalSears Jul 1998 - Dec 2002Chicago, Il, Us• Provided excellent customer service.• Handled customer problems.• Sold merchandise in a competitive environment.
David Roach Skills
Hplc
Analytical Chemistry
Ftir
Change Control
Chemistry
Computer System Validation
Ir
Nir Spectroscopy
Organic Chemistry
Inorganic Chemistry
Sql*plus
Quality Center
Teaching
Direct Sales
Icp
21 Cfr Part 11
Software Documentation
Scuba Diving
Nmr
Compliance
Nmr Spectroscopy
Gc/ms
Nir
Sop
Active Directory
Project Implementation
Software Implementation
Windows 7
Windows Server
Empower
Test Scripts
Hp Quality Center
Trend Micro Anti Virus
Remote Troubleshooting
Compliance Remediation
Data Migration
Lims
Pharmaceutical Industry
Glp
Validation
Dissolution
Laboratory
Uv/vis
Lc Ms
Gmp
David Roach Education Details
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Virginia TechAnalytical Chemistry -
Virginia TechChemistry
Frequently Asked Questions about David Roach
What company does David Roach work for?
David Roach works for Novo Nordisk
What is David Roach's role at the current company?
David Roach's current role is IT Compliance Manager, Manufacturing IT - Injectable Finished Products at Novo Nordisk.
What is David Roach's email address?
David Roach's email address is daroach@vt.edu
What schools did David Roach attend?
David Roach attended Virginia Tech, Virginia Tech.
What are some of David Roach's interests?
David Roach has interest in Animal Welfare, Education, Environment, Science And Technology.
What skills is David Roach known for?
David Roach has skills like Hplc, Analytical Chemistry, Ftir, Change Control, Chemistry, Computer System Validation, Ir, Nir Spectroscopy, Organic Chemistry, Inorganic Chemistry, Sql*plus, Quality Center.
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