Marlena Nowak

do-it GROUP Owner at do-it GROUP - Gdańsk, pomorskie, Poland

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***@do-itgroup.pl
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(XXX) XXX-XXXX
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Location
Gdańsk,Pomeranian Voivodeship,Poland
Company
do-it GROUP
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do-it GROUP logo, do-it GROUP contact details

do-it GROUP

Gdańsk, pomorskie, Poland • 1 Employees
Pharmaceuticals

After 24 years of work in Pharmaceutical companies, in various quality areas, I would like to share my knowledge with different business partners (eg. pharmaceutical/biotechnology companies, API manufacturers, packaging materials manufacturers, etc ) who need support in the following areas: Departmental QA leadership:- External QA Head/leadership roles (interim management) Operational GxP support:- Operational excellence projects in Quality Management Systems area- Quality management system set-up / redesign - GMP core processes for API/drug product: release management, change management, deviation & CAPA management, - Audits, audit/inspection preparation, management & follow-up (across GxPs) - Quality management systems (across GxPs): documentation, training, risk management- Quality Culture implementation/improvement- Reocurring deviations related to mix-ups - Lean Quality Management System- Lean Lab (visualization of indicators, 6S, standardization, optimization, waste management, morning meetings, etc)- ISO 9001

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