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@takeda.com
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2 phones found area 847 and 630
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Brian Rosemann is listed as Quality Manager - Design Control (Senior Quality Systems Consultant) at Takeda at Takeda, a company with 32621 employees, based in Trevor, Wisconsin, United States. AeroLeads shows a work email signal at takeda.com, phone signal with area code 847, 630, and a matched LinkedIn profile for Brian Rosemann.
Brian Rosemann previously worked as Quality Manager - Design Control (Senior Quality Systems Consultant) at Takeda and Corporate Product Surveillance Supervisor at Baxter. Brian Rosemann holds Ba, Physics from Knox College.
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AeroLeads found 1 current-domain work email signal for Brian Rosemann. Compare company email patterns before reaching out.
- Knowledge of Food and Drug Administration (FDA) Quality System and Medical Device Reporting Regulations (21 Code of Federal Regulations (CFR) 820, 803, and 211), and ISO-13485- Pharmaceutical and medical device experience in Quality including 7 years of supervisory and 5 years of aseptic manufacturing plant experience. - Experience includes compliance tasks such as: implementing and reporting metrics/KPIs to management on an on-going basis; writing, reviewing, and approving non-conformances and CAPAs, IQ/OQ/PQ protocols, and standard operating procedures; subject matter expert for internal and external audits (FDA); perform training on procedures, specifications, and performance of assigned tasks. - Extensive knowledge in equipment / system and document change control processes. Assess impact of changes on validation status, processes, procedures, prints, and regulatory submissions. Performed risk assessments to develop the requirements and specifications for changes. - Lead and participate on cross-functional teams with participants both internal and external to company.
Listed skills include Capa, Gmp, Fda, Quality System, and 20 others.
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Bannockburn, IL
- Analyze business processes and create system documentation including design and development plan, system requirements, and functional specifications. Ensure compliance of system documentation with procedures and regulatory requirements. - Facilitate risk assessment activities as part of the design control process. - Provide guidance in interpretation and.
Round Lake, IL
- Supervise 17 employees in facilitating complaint handling processes such as incoming phone call and regulatory reporting (approximately 15,000 complaints a month).- Triage teams’ workflows and create performance metrics to monitor goals and work in process for executive management. - Provide direct supervision of individuals including mentoring.
Round Lake, IL
- Create and analyze Field Corrective Action (FCA) metrics and reports for business review and Quality Leadership Team meetings.- Provide accurate and timely data for Regulatory requests, internal and external audits, and ad-hoc requests.- Team member on global process improvements with multi-functional organizations including regional and divisional.
Round Lake, IL
Work in Quality Operation Group within a pharmaceutical production facility that utilizes aseptic manufacturing technology. - Support the move of the GLP manufacturing facility pilot plant facility to GMP phase 1 clinical trial facility including validation activities, SOP updates, and process development. - Responsible for inventory levels, warehousing.
Round Lake, IL
Manage a staff of 4 employees in the Calibration Laboratory within a commercial pharmaceutical production facility that utilizes aseptic manufacturing technologies. Operate the calibration program (approximately 4,500 calibrations per year) for the production facility and also support the maintenance and introduction of all critical systems within the.
Other employees you can reach at takeda.com. View company contacts for 32621 employees →
Raelynn Dasilva
Colleague at Takeda
Atlanta Metropolitan Area, United States
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AF
Andrea Ferreira
Colleague at Takeda
Jaguariúna, São Paulo, Brazil, Brazil
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ES
Eric Schmidt
Colleague at Takeda
Greater Boston, United States
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IS
Imane Saidi
Colleague at Takeda
France, France
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AD
Anna Dontsenko
Colleague at Takeda
Russia, Russian Federation
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SM
Shokyo Miki
Colleague at Takeda
Japan, Japan
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CG
Carolina Gallo
Colleague at Takeda
Campinas, São Paulo, Brazil, Brazil
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PA
Paula Almeida
Colleague at Takeda
São Paulo, São Paulo, Brazil, Brazil
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SR
Shawn Rohen
Colleague at Takeda
Attleboro, Massachusetts, United States, United States
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HU
Helmuth Unger
Colleague at Takeda
Austria, Austria
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Quick answers generated from the profile data available on this page.
Brian Rosemann works for Takeda.
Brian Rosemann is listed as Quality Manager - Design Control (Senior Quality Systems Consultant) at Takeda at Takeda.
AeroLeads has found 1 work email signal at @takeda.com for Brian Rosemann at Takeda.
AeroLeads has found 2 phone signal(s) with area code 847, 630 for Brian Rosemann at Takeda.
Brian Rosemann is based in Trevor, Wisconsin, United States while working with Takeda.
Brian Rosemann has worked for Takeda and Baxter.
Brian Rosemann's colleagues at Takeda include Raelynn Dasilva, Andrea Ferreira, Eric Schmidt, Imane Saidi, and Anna Dontsenko.
You can use AeroLeads to view verified contact signals for Brian Rosemann at Takeda, including work email, phone, and LinkedIn data when available.
Brian Rosemann holds Ba, Physics from Knox College.
Brian Rosemann is listed with skills including Capa, Gmp, Fda, Quality System, Change Control, Validation, Quality Assurance, and Medical Devices.
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