CLINICAL TRIAL PRODUCT RELEASE QA

POSITION SUMMARY: To support clinical trial for biotech companies Pharma IT is searching for a Clinical Trial Product Release QA. The Clinical Trial Product Release QA will provide manufacturing QA support in accordance with documented procedures and practices and be responsible for continuous reinforcement of established Quality Assurance fundamental practices and improvements if needed. Furthermore …

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SAFe – Agile

Last week 15 senior Compliance- and Project Managers from Pharma IT participated in a Leading SAFe training session. Building on LEAN,  Agile/Scrum and System Thinking,  SAFe is a framework that allows large organizations a means to reap the benefits of agile development. SAFe promotes alignment, collaboration and delivery across large numbers of agile teams. The …

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Medical Device Engineers – Side job/Freelance

Pharma IT is searching for Medical Device Engineers to support development/assessment of Medical Device products within all the different types of Medical Devices as defined in EU REGULATION 2017/2185 – Link Our aim is to build a competence database of Medical Device Engineers, who can support our customers within development/test/assessment of Medical Devices on a freelance …

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Steen Lindebjerg passes CIPP/E

Steen Lindebjerg, one of our Data Protection and GDPR specialists, just passed his CIPP/E exam this week.  CIPP is Certified Information Privacy Professional Europe and it encompasses pan-European and national data protection laws, key privacy terminology and practical concepts concerning the protection of personal data and trans-border data flows.  Passing the exam shows that Steen …

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Pharma IT is searching for freelance consultants

Pharma IT is searching for freelance consultants with experience from the Pharmaceutical, Biotech and Medical Device industry. Pharma IT is experiencing an increase in customer requests and we need additional help to fulfill our customers needs. If you are a freelancer with knowledge and experience from the Pharmaceutical sector, please feel free to register your …

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Cost effective turn-key solution for becoming compliant with MDR and IVDR by May 2020/2022

Small and medium size medical device companies By May 2020 medical devices companies will have to comply with the new EU Medical Device Regulation (MDR). For Vitro Medical Devices (IVMD) the date is May 2022. The regulation holds several new and/or increased requirements that must be adhered to: Implementation of a Quality Management System, with …

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Data Integrity

Data Integrity is an increasingly important topic in the Pharmaceutical Sector. Partly because it is on the agenda with the regulatory bodies and a topic for inspections, resulting in a significant number of observations, FDA Warning Letters and EU Non-Compliance Reports.   Specializing in Pharma and IT we have been assisting preparing for a Pre-Approval …

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