PR QualityConsultancy GmbH is a company for consultancy in all fields of pharmaceutical / biopharmaceutical /medical device manufacturing and related businesses worldwide.
You need additional expertise or qualified resources for your company or you have a problem related to manufacturing, PR QualityConsultancy can support you with solutions and assessements using Lean SixSigma, GMP-Audits or providing projectmanagement.
Quality and motivation for effective and efficient solutions is the expertise of PR QualityConsultancy. Audits are performed with the goal of gaining value to all parties: Customers get an overview on the real quality standards of their suppliers and the supplier recieves advice and support to improve their product-quality from an independent company.
"No audit-tourism": The overall costs and time-consumption for organizing, planning, travelling and performing qualified audits are too high for all participating parties to be performed without adding value to an organization.
PR QualityConsultancy has the target to contribute value, to be truthful and reliable internal as well as confidential external.
Audits can be performed independent or in combination with your own experts.
My company is oriented to improve the quality of my customers in the field of manufacturing and supplier/CMO quality worldwide. This covers process improvement, quality assessment and technical root cause investigation.
Over 16 years technical experience in pharmaceutical and chemical technology / engineering, R&D and commercial manufacturing processes as well as quality systems, worldwide supplier-assessment/development and trouble shooting mainly in English or German language.
My educational background is a scientific BSc,MSc / Dipl.-Ing. (Univ.) in BioChemical process engineering from the University of Stuttgart with the main subjects biotechnology, biomedical engineering and chemical reaction engineering. I have 8 years experience as GMP-Lead Auditor worldwide (ECA/APIC-certified; America, Europe, Asia, Australia), hosting authority inspections or for-cause audits by customers, as Lean SixSigma Black Belt and overall 12 years experience in the global pharmaceutical and biotechnology business, with an overview from more than 120 manufacturing sites. This includes 'TOP 10 - big pharma' as well as smaller Biotechnology companies
The network can contribute additional expertise and resources to meet customer's needs. For example, language support for different countries. Our customers are our best proof for quality. We appreciate to be also your contact of choice.
The following service is provided in sterile and non-sterile GMP-manufacturing of bio-/ pharmaceutical API (active pharmaceutical ingredients) and production of FDF (finished dosage forms - liquid/ oral) as well as pharmaceutical excipients and medical devices. Additional this service can be applied in all related supplying businesses (manufacturing equipment and raw materials, clean-rooms, primary and secondary packaging, detergents, disinfectants, disposable equipments etc.)
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