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Roksana John is listed as Sr. Validation Lead at USDM Life Sciences at USDM Life Sciences, a company with 164 employees, based in Seligenstadt, Hesse, Germany. AeroLeads shows a matched LinkedIn profile for Roksana John.
Roksana John previously worked as Project Specialist Digital Validation at Fresenius Kabi and Senior IT QA Specialist at Ergomed. Roksana John holds Postgraduate Study, Design Of Information Systems & Databases from Politechnika Warszawska.
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As a Senior Validation Lead at USDM Life Sciences, I apply my 12+ years of experience and knowledge in the pharmaceutical industry and clinical trials to ensure the quality and compliance of computerized systems and software. I hold ITIL and ISTQB certifications and have a strong background in biotechnology and information systems design.My core competencies include managing business IT audits and inspections, acting as an IT QA and CSV subject matter expert, authoring, reviewing, and approving IT quality policy and processes, performing periodic reviews and risk assessments. I am passionate about learning new things and developing myself, and I am detail and quality oriented. I aim to contribute to the success and innovation of USDM Life Sciences.
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Germany (remote)
USDM Life Sciences is the leading global technology consulting firm focused on digital transformation, regulated and unregulated data management and compliance solutions for the world’s leading and emerging biotechnology, pharmaceutical and medical device companies. As Sr. Validation Lead, I’m responsible for computerized system validation projects and.
Frankfurt Am Main
Managing Business IT Audits/Inspections & client/regulatory responses - Acting as IT QA and CSV SME on a range of IT system implementations, producing validation deliverables across the full SDLC lifecycle - Authoring, reviewing or approving IT quality policy and processes as Subject Matter Expert for continuous improvements, and further development.
-Collaborates with other QA Leads to support the global internal and external audit program.-Responsible for supporting review of validation documentation related to computerized systems, software, and IT infrastructure to ensure the maintenance of compliance according to company standards, industry standards, and regulatory requirements-Responsible for.
Warszawa, woj. Mazowieckie, Polska
- acting as Quality Lead and/or Test Lead during IRT system set-up (UAT)- Validation Plans, Test Plans, Risk Assessment, Tractability Matrix devising - responsible for the coordination/leading activities ensuring lifecycle management and business continuity for Clinical Operation processes and tools
Warsaw, Masovian District, Poland
-Providing validation support for IT projects across all stages of the Software Development Lifecycle (SDLC), including definition, design, testing and building, operation and maintenance, and system retirement. - Developing Validation Plans, Validation Reports, Traceability Matrices, and Validation Registries.- Offering guidance on System Level and.
Pomeranian District, Starogard Gdański, Polska
- Development of analytical procedures (including pre-validation)- Conducting analytical tests during the R&D stage- Elaboration of the CTD documentation for medical products- Evaluation of the ASMF documentation provided by manufacturers of active substances
Wroclaw, Lower Silesian District, Poland
- Projects coordination, including planning and conduct of pre-formulation studies- Development of analytical procedures (including pre-validation)- Elaboration of registration documentation (CTD), internal documentation (including specification for active substance and medical products) and annual product reports- Development and validation of analytical.
Wrocław Area, Poland
Elaboration of system and registration documentation; Preparation of Annual Product Reports for medical products; Analytical methods validation (for cleaning validation process)
Other employees you can reach at usdm.com. View company contacts for 164 employees →
Geoffrey Wilson
Colleague at Usdm Life Sciences
San Francisco Bay Area, United States
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BG
Brittany Garfield
Colleague at Usdm Life Sciences
Las Vegas, Nevada, United States, United States
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CU
Chaithanya U K
Colleague at Usdm Life Sciences
Bengaluru, Karnataka, India, India
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PM
Peter Morse
Colleague at Usdm Life Sciences
New York City Metropolitan Area, United States
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BM
Brett Malikowski
Colleague at Usdm Life Sciences
Costa Mesa, California, United States, United States
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LG
Lauren Galvin
Colleague at Usdm Life Sciences
Santa Barbara, California, United States, United States
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ST
Stefka Tzoneva
Colleague at Usdm Life Sciences
Bulgaria, Bulgaria
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HK
Hussam Kazi, Mba, Pmp
Colleague at Usdm Life Sciences
Ventura County, California, United States, United States
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DK
Daria Konicka - Madyun
Colleague at Usdm Life Sciences
Greater Boston, United States
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CW
Cheryl Whalen
Colleague at Usdm Life Sciences
Greater Boston, United States
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Quick answers generated from the profile data available on this page.
Roksana John works for USDM Life Sciences.
Roksana John is listed as Sr. Validation Lead at USDM Life Sciences at USDM Life Sciences.
Roksana John is based in Seligenstadt, Hesse, Germany while working with USDM Life Sciences.
Roksana John has worked for Usdm Life Sciences, Fresenius Kabi, Ergomed, Synteract, and Astrazeneca.
Roksana John's colleagues at USDM Life Sciences include Geoffrey Wilson, Brittany Garfield, Chaithanya U K, Peter Morse, and Brett Malikowski.
You can use AeroLeads to view verified contact signals for Roksana John at USDM Life Sciences, including work email, phone, and LinkedIn data when available.
Roksana John holds Postgraduate Study, Design Of Information Systems & Databases from Politechnika Warszawska.
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