GMP Specialist

Dorota Osińska is a Pharmacist with over the 20 years experience in pharmaceutical industry. She worked in the research department of a pharmaceutical company developing and implementing oral pharmaceutical forms. She has been a lead expert in validation and audits in Quality Assurance and Quality Assurance and Qualified Operations Manager at Polfa Warszawa S.A. (Polpharma Group) as well as the Manager of Compliance and Quality Assurance Compliance Team at Agila Specialties Polska (Mylan Group).

She participated in designing and launching new production areas and upgrading existing ones. As a quality specialist, she participated in the implementation of Good Manufacturing Practice requirements. She was an internal auditor and external auditor, auditing the manufacturers of active substances, packaging materials, medical devices, contract manufacturers and pharmacovigilance.

She oversaw the development of quality contracts, development of DGMW, complaint handling, qualitative documentation management, deviation analysis, supplier qualification, corrective and preventive actions, internal training, internal inspections and external audits.

Ms Dorota Osińska has started GMP certification process in the field of labelling, re-labelling and re-packing of investigational products.

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Safety and Pharmacokinetics of JAK/ROCK Inhibitor in Healthy Volunteers

In BRG we are just starting Study for Healthy People with an Immune Drug - Part B. The aim of the following clinical trial...

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Merry Christmas and Happy New Year

Let the magical night of Christmas Eve bring peace and joy. Let every moment of Christmas live with its own beauty, and bestows the New Year with prosperity and happiness.

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COVID -19 Antigen Tests:

On 31st of October 2020, the Chief Sanitary Inspectorate confirmed that the antigen cassette tests are the same basis for determining the SARS-CoV-2 ...

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BRG team participated in BIO-Europe®

On 26th -27th  of October BRG team participated in BIO-Europe® the largest partnering conference in Europe dedicated to the global biotechnology industry. 

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