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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Phase IIa diabetes study termination

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Lets play till the end of the world and one day longer!

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